PrematurityDINENCT03061890
Developmental Impact of NICU Exposures (DINE)
An observational study of Prematurity, run by Albert Einstein College of Medicine at 11 sites in United States.
Trial summary
The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Prematurity
- How many people
- 600 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Apr 2017to 31 Aug 2023
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Child
Study population: Former preterm infants who were participants hospitalized in the NICU of one of the 8 clinical sites participating in the UH3 phase of the ECHO and DINE studies and whose parents had consented to participate in one of the 4 extent cohorts of the following NIH-supported studies: Prematurity and Respiratory Outcomes Program (PROP), the Trial of Late Surfactant (TOLSURF), the NICU Hospital Exposures and Long-Term Health (NICU-HEALTH) study and the Preterm Erythropoietin Neuroprotection Trial (PENUT) study and agreed to longitudinal follow up of infants as part of DINE
Who may be able to join
- Children who were study participants in one of the four extant preterm cohorts (PROP, TOLSURF, NICU-HEALTH, and PENUT) that comprise the combined DINE cohort and who were followed to study endpoint at one of the clinical sites in DINE.
- Newly recruited preterm infants admitted to the NICU at the Icahn School of Medicine at Mount Sinai
- Newly recruited preterm and term infants who participated in the PRISM study at University of Rochester
- Parents agreed to be re-contacted or local Institutional Review Board (IRB) grants permission to recontact families to obtain consent to participate in DINE.
Who cannot join
- Family requested that they not be contacted after their child completed the parent study
- Family is unlikely to be available for long-term follow-up
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
National Institute for Children's Health Quality
Boston, Massachusetts, 02108
University at Buffalo State University of New York
Buffalo, New York, 14222
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Florida
Jacksonville, Florida, 32209
Children's Health Care, Inc.
Minneapolis, Minnesota, 55404
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Rochester
Rochester, New York, 14642
University of Washington
Seattle, Washington, 98195
Albert Einstein College of Medicine
The Bronx, New York, 10461
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27103
About this study
Official title: Developmental Impact of Neonatal Intensive Care Unit (NICU) Exposures: Environmental Influences on Child Health Outcomes (ECHO)
The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.
Read the detailed description
Background: Each year in the United States, over 300,000 preterm infants are admitted to neonatal intensive care units (NICUs) where they are exposed to a chemical-intensive hospital environment during a developmentally vulnerable period. Many life-saving and supportive respiratory, nutritional, hematologic and pharmaceutical therapies in the NICU expose preterm infants to potentially harmful chemicals during a life stage analogous to the third trimester of gestation. The NIH-funded DINE study capitalizes on the infrastructure, biorepositories, and extensive clinical databases of four existing preterm cohorts to explore the hypothesis that early life exposure to phthalates adversely impacts neurodevelopment, lung function, growth, adiposity, and pubertal development in childhood.
The scientific premise of the DINE study is that early life exposure to phthalates, a class of chemical plasticizers ubiquitous in the NICU, has long-lasting harmful effects on child health and development, and that these harmful effects are magnified in children born preterm. This premise is based on strong evidence of multisystem adverse health effects in term-born children who are exposed to phthalates in utero during the third trimester of pregnancy or in early infancy. In preterm infants, however, rigorously obtained data on the health effects of phthalates are scant. Dermal, inhalational and intravenous exposures to phthalates are widespread in some NICUs, where preterm infants are cared for during the sensitive "third trimester" developmental window. Moreover, premature infants experience a high prevalence of the adverse health effects that are associated with early life exposures to phthalates in term-born children, including altered neurodevelopment, poor pulmonary function, and maladapted growth. A rigorous, well-designed, sufficiently powered study of NICU-based phthalate exposures and long-term health outcomes of preterm infants has the potential to change care practices, promote regulatory policy changes and lead to mitigation of phthalate exposures in the NICU.
Significance: The proposed research is expected to identify modifiable sources of developmental risk for NICU patients that can inform and improve hospital care and long-term outcome. Moreover, our findings could lead to relatively inexpensive NICU interventions, such as use of non-phthalate containing medical materials, dosing guidelines for elemental metals and guidance for parents and staff on infant stress-reduction, and policy changes (e.g. regulation of the phthalates used in medical devices or changes to the trace metal content of parenteral nutrition) with significant positive potential impacts on life-long morbidities common among NICU graduates. Information gleaned from studying our highly-exposed, highly-vulnerable population may elucidate health impacts of early life exposures that translate to risk reduction in the general population.
- Conditions
- Prematurity
- Keywords
- children's environmental health, prematurity, preterm birth, phthalates, NICU, stress, lung health, neurodevelopment, growth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prematurity and Respiratory Outcomes Program (PROP) | extant, NIH-supported preterm birth cohort NCT01435187 | |
| Trial of Late Surfactant (TOLSURF) | extant, NIH-supported preterm birth cohort NCT01022580 | |
| NICU Hospital Exposures and Long-Term Health (NICU-HEALTH) | extant, NIH-supported preterm birth cohort NCT01963065 | |
| Preterm Erythropoietin Neuroprotection Trial (PENUT) | extant, NIH-supported preterm birth cohort NCT01378273 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between NICU environmental exposures and lung health and asthma measured by Brief Respiratory Questionnaire
Brief Respiratory Questionnaire to determine association between exposure and lung health
Measured: One time between the ages of 3 to 4
Associations between NICU environmental exposures and lung health and asthma measured by the PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Asthma Impact item bank
PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Asthma Impact item bank to determine association between exposure and asthma
Measured: One time between the ages of 5 to 6
Associations between NICU environmental exposures and lung health and asthma measured by PhenX (consensus measures for Phenotypes and eXposures) Toolkit measures of spirometry and bronchodilator responsiveness
PhenX (consensus measures for Phenotypes and eXposures) Toolkit measures of spirometry and bronchodilator responsiveness to determine association between exposure and asthma
Measured: Twice between the ages of 8 to 12
Associations between NICU environmental exposures and lung health and asthma measured by the PROMIS Pediatric Asthma Impact item bank.
PROMIS Pediatric Asthma Impact item bank to determine the association between exposures and asthma
Measured: Twice between the ages of 8 to 12
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Early Childhood Cognition Battery
NIH Toolbox Early Childhood Cognition Battery to determine the associations between exposures and neurocognitive behavioral development
Measured: Twice within 24 months between the ages of 3 to 5
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Cognition Battery
NIH Toolbox Cognition Battery to determine the associations between exposures and neurocognitive behavioral development
Measured: Twice within 24 months between the ages of 7 to 9
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Early Childhood Motor Battery
NIH Toolbox Early Childhood Motor Battery to determine the associations between exposures and neurocognitive behavioral development
Measured: Twice within 24 months between the ages of 4 to 6
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Motor Battery
NIH Toolbox Motor Battery to determine the associations between exposures and neurocognitive behavioral development
Measured: Twice between the ages of 8 to 12
Associations between NICU environmental exposures and neurocognitive behavioral development measured by Child Behavior Checklist (CBCL)
Child Behavior Checklist (CBCL) to determine the associations between exposures and neurocognitive behavioral development
Measured: One time between the ages of 3 to 4
Associations between NICU environmental exposures and neurocognitive behavioral development measured by PROMIS Cognitive Item bank
PROMIS Cognitive Item bank to determine the associations between exposures and neurocognitive behavioral development
Measured: Three times between the ages of 5 to 12
Associations between NICU environmental exposures and neurocognitive behavioral development measured by PROMIS Pediatric Mobility Item bank
PROMIS Pediatric Mobility Item bank to determine the associations between exposures and neurocognitive behavioral development
Measured: Three times between the ages of 5 to 12
Associations between NICU environmental exposures and neurocognitive behavioral development measured by PROMIS Pediatric Upper Extremity Item bank
PROMIS Pediatric Upper Extremity Item to determine the associations between exposures and neurocognitive behavioral development
Measured: Three times between the ages of 5 to 12
Associations between NICU environmental exposures and growth and obesity as measured by height, weight, head circumference, mid-upper arm circumference and bioimpedence
Measurement of height, weight, head circumference, mid-upper arm circumference and bioimpedence scale to determine associations between exposures and heathy growth and obesity
Measured: Annually, up to 12 years
Associations between NICU environmental exposures and growth and obesity as measured by parent report height and weight
Parent reported height and weight to determine associations between exposures and healthy growth and obesity
Measured: Annually, up to 12 years
Associations between NICU environmental exposures and pubertal development measured by PhenX Assessment of Pubertal Development
PhenX Assessment of Pubertal Development to determine associations between exposures and pubertal development
Measured: Annually, up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Apr 2017
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Judy Aschner, Albert Einstein College of Medicine
- Investigators
- Judy L Aschner, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061890
- Sponsor's protocol ID
- 2016-7369
- Other IDs
- UG3OD023320, UH3OD023320
- Acronym
- DINE
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2017
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All efforts, within reason, are made to keep protected health information (PHI) private, including data gathered for research studies. Using or sharing ("disclosure") such data must follow federal privacy rules. All PHI about children in the study will be entered into REDCap, a secure, web-based data collection platform. Study patients will be identified only by a study identification (ID) number. Access to the REDCap study database is restricted to study personnel, password protected and behind a Medical Center firewall. The study child's name and medical record number will appear only on the Screening Log which contains no other PHI. Only the study team will have access to the Screening Log.
Publications
Aschner JL, Bancalari EH, McEvoy CT. Can We Prevent Bronchopulmonary Dysplasia? J Pediatr. 2017 Oct;189:26-30. doi: 10.1016/j.jpeds.2017.08.005. No abstract available.
PubMed 28947055Wright RO, Teitelbaum S, Thompson C, Balshaw D; CHEAR Network. The child health exposure analysis resource as a vehicle to measure environment in the environmental influences on child health outcomes program. Curr Opin Pediatr. 2018 Apr;30(2):285-291. doi: 10.1097/MOP.0000000000000601.
PubMed 29406438Zhang X, Smith N, Spear E, Stroustrup A. Neighborhood characteristics associated with COVID-19 burden-the modifying effect of age. J Expo Sci Environ Epidemiol. 2021 May;31(3):525-537. doi: 10.1038/s41370-021-00329-1. Epub 2021 May 4.
PubMed 33947953Stroustrup A, Teitelbaum SL, Aschner JL. The Value of Preterm Infant Environmental Health Cohorts: The Canary in the Coal Mine. JAMA Pediatr. 2017 Dec 1;171(12):1139-1140. doi: 10.1001/jamapediatrics.2017.3230. No abstract available.
PubMed 29059271Stroustrup A, Bragg JB, Andra SS, Curtin PC, Spear EA, Sison DB, Just AC, Arora M, Gennings C. Neonatal intensive care unit phthalate exposure and preterm infant neurobehavioral performance. PLoS One. 2018 Mar 5;13(3):e0193835. doi: 10.1371/journal.pone.0193835. eCollection 2018.
PubMed 29505594Stroustrup A, Bragg JB, Busgang SA, Andra SS, Curtin P, Spear EA, Just AC, Arora M, Gennings C. Sources of clinically significant neonatal intensive care unit phthalate exposure. J Expo Sci Environ Epidemiol. 2020 Jan;30(1):137-148. doi: 10.1038/s41370-018-0069-2. Epub 2018 Sep 21.
PubMed 30242269Conradt E, Flannery T, Aschner JL, Annett RD, Croen LA, Duarte CS, Friedman AM, Guille C, Hedderson MM, Hofheimer JA, Jones MR, Ladd-Acosta C, McGrath M, Moreland A, Neiderhiser JM, Nguyen RHN, Posner J, Ross JL, Savitz DA, Ondersma SJ, Lester BM. Prenatal Opioid Exposure: Neurodevelopmental Consequences and Future Research Priorities. Pediatrics. 2019 Sep;144(3):e20190128. doi: 10.1542/peds.2019-0128.
PubMed 31462446Tylavsky FA, Ferrara A, Catellier DJ, Oken E, Li X, Law A, Dabelea D, Rundle A, Gilbert-Diamond D, Hivert MF, Breton CV, Cassidy-Bushrow AE, Mueller NT, Hunt KJ, Arteaga SS, Lombo T, Mahabir S, Ruden D, Sauder K, Hedderson MM, Zhu Y, Polk S, Mihalopoulos NL, Vos M, Pyles L, Roary M, Aschner J, Karagas MR, Trasande L. Understanding childhood obesity in the US: the NIH environmental influences on child health outcomes (ECHO) program. Int J Obes (Lond). 2020 Mar;44(3):617-627. doi: 10.1038/s41366-019-0470-5. Epub 2019 Oct 24.
PubMed 31649277Pourkaviani S, Zhang X, Spear EA, D'Agostino M, Satty RE, Liu SH, Stroustrup A. Clinical validation of the Neonatal Infant Stressor Scale with preterm infant salivary cortisol. Pediatr Res. 2020 Jun;87(7):1237-1243. doi: 10.1038/s41390-019-0713-0. Epub 2019 Dec 17.
PubMed 31847006Stroustrup A, Bragg JB, Spear EA, Aguiar A, Zimmerman E, Isler JR, Busgang SA, Curtin PC, Gennings C, Andra SS, Arora M. Cohort profile: the Neonatal Intensive Care Unit Hospital Exposures and Long-Term Health (NICU-HEALTH) cohort, a prospective preterm birth cohort in New York City. BMJ Open. 2019 Nov 25;9(11):e032758. doi: 10.1136/bmjopen-2019-032758.
PubMed 31772104Faro EZ, Sauder KA, Anderson AL, Dunlop AL, Kerver JM, McGrath M, Roary M, Roman CW, Weidinger C, Huddleston KC. Characteristics of Environmental influences on Child Health Outcomes (ECHO) Cohorts Recruited During Pregnancy. MCN Am J Matern Child Nurs. 2021 Jul-Aug 01;46(4):230-235. doi: 10.1097/NMC.0000000000000725.
PubMed 33993167Schantz SL, Eskenazi B, Buckley JP, Braun JM, Sprowles JN, Bennett DH, Cordero J, Frazier JA, Lewis J, Hertz-Picciotto I, Lyall K, Nozadi SS, Sagiv S, Stroustrup A, Volk HE, Watkins DJ; program collaborators for Environmental influences on Child Health Outcomes. A framework for assessing the impact of chemical exposures on neurodevelopment in ECHO: Opportunities and challenges. Environ Res. 2020 Sep;188:109709. doi: 10.1016/j.envres.2020.109709. Epub 2020 May 23.
PubMed 32526495Zhang X, Spear E, Gennings C, Curtin PC, Just AC, Bragg JB, Stroustrup A. The association of prenatal exposure to intensive traffic with early preterm infant neurobehavioral development as reflected by the NICU Network Neurobehavioral Scale (NNNS). Environ Res. 2020 Apr;183:109204. doi: 10.1016/j.envres.2020.109204. Epub 2020 Jan 31.
PubMed 32311904Stratakis N, Garcia E, Chandran A, Hsu T, Alshawabkeh A, Aris IM, Aschner JL, Breton C, Burbank A, Camargo CA Jr, Carroll KN, Chen Z, Claud EC, Dabelea D, Dunlop AL, Elliott AJ, Ferrara A, Ganiban JM, Gern JE, Gold DR, Gower WA, Hertz-Picciotto I, Karagas MR, Karr CJ, Lester B, Leve LD, Litonjua AA, Ludena Y, McEvoy CT, Miller RL, Mueller NT, O'Connor TG, Oken E, O'Shea TM, Perera F, Stanford JB, Rivera-Spoljaric K, Rundle A, Trasande L, Wright RJ, Zhang Y, Zhu Y, Berhane K, Gilliland F, Chatzi L; on behalf of program collaborators for Environmental Influences on Child Health Outcomes. The Role of Childhood Asthma in Obesity Development: A Nationwide US Multicohort Study. Epidemiology. 2022 Jan 1;33(1):131-140. doi: 10.1097/EDE.0000000000001421.
PubMed 34561347Lyall K, Ning X, Aschner JL, Avalos LA, Bennett DH, Bilder DA, Bush NR, Carroll KN, Chu SH, Croen LA, Dabelea D, Daniels JL, Duarte C, Elliott AJ, Fallin MD, Ferrara A, Hertz-Picciotto I, Hipwell AE, Jensen ET, Johnson SL, Joseph RM, Karagas M, Kelly RS, Lester BM, Margolis A, McEvoy CT, Messinger D, Neiderhiser JM, O'Connor TG, Oken E, Sathyanarayana S, Schmidt RJ, Sheinkopf SJ, Talge NM, Turi KN, Wright RJ, Zhao Q, Newschaffer C, Volk HE, Ladd-Acosta C, Environmental Influences On Child Health Outcomes OBOPCF. Cardiometabolic Pregnancy Complications in Association With Autism-Related Traits as Measured by the Social Responsiveness Scale in ECHO. Am J Epidemiol. 2022 Jul 23;191(8):1407-1419. doi: 10.1093/aje/kwac061.
PubMed 35362025
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Impact of Neonatal Intensive Care Unit (NICU) Exposures: Environmental Influences on Child Health Outcomes (ECHO)
- ClinicalTrials.gov ID
- NCT03061890
- Acronym / sponsor ID
- DINE / 2016-7369
- Conditions
- Prematurity
- Keywords
- children's environmental health, prematurity, preterm birth, phthalates, NICU, stress, lung health, neurodevelopment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.
Detailed description
Background: Each year in the United States, over 300,000 preterm infants are admitted to neonatal intensive care units (NICUs) where they are exposed to a chemical-intensive hospital environment during a developmentally vulnerable period. Many life-saving and supportive respiratory, nutritional, hematologic and pharmaceutical therapies in the NICU expose preterm infants to potentially harmful chemicals during a life stage analogous to the third trimester of gestation. The NIH-funded DINE study capitalizes on the infrastructure, biorepositories, and extensive clinical databases of four existing preterm cohorts to explore the hypothesis that early life exposure to phthalates adversely impacts neurodevelopment, lung function, growth, adiposity, and pubertal development in childhood.
The scientific premise of the DINE study is that early life exposure to phthalates, a class of chemical plasticizers ubiquitous in the NICU, has long-lasting harmful effects on child health and development, and that these harmful effects are magnified in children born preterm. This premise is based on strong evidence of multisystem adverse health effects in term-born children who are exposed to phthalates in utero during the third trimester of pregnancy or in early infancy. In preterm infants, however, rigorously obtained data on the health effects of phthalates are scant. Dermal, inhalational and intravenous exposures to phthalates are widespread in some NICUs, where preterm infants are cared for during the sensitive "third trimester" developmental window. Moreover, premature infants experience a high prevalence of the adverse health effects that are associated with early life exposures to phthalates in term-born children, including altered neurodevelopment, poor pulmonary function, and maladapted growth. A rigorous, well-designed, sufficiently powered study of NICU-based phthalate exposures and long-term health outcomes of preterm infants has the potential to change care practices, promote regulatory policy changes and lead to mitigation of phthalate exposures in the NICU.
Significance: The proposed research is expected to identify modifiable sources of developmental risk for NICU patients that can inform and improve hospital care and long-term outcome. Moreover, our findings could lead to relatively inexpensive NICU interventions, such as use of non-phthalate containing medical materials, dosing guidelines for elemental metals and guidance for parents and staff on infant stress-reduction, and policy changes (e.g. regulation of the phthalates used in medical devices or changes to the trace metal content of parenteral nutrition) with significant positive potential impacts on life-long morbidities common among NICU graduates. Information gleaned from studying our highly-exposed, highly-vulnerable population may elucidate health impacts of early life exposures that translate to risk reduction in the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prematurity and Respiratory Outcomes Program (PROP) | – | –extant, NIH-supported preterm birth cohort NCT01435187 |
| Trial of Late Surfactant (TOLSURF) | – | –extant, NIH-supported preterm birth cohort NCT01022580 |
| NICU Hospital Exposures and Long-Term Health (NICU-HEALTH) | – | –extant, NIH-supported preterm birth cohort NCT01963065 |
| Preterm Erythropoietin Neuroprotection Trial (PENUT) | – | –extant, NIH-supported preterm birth cohort NCT01378273 |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Former preterm infants who were participants hospitalized in the NICU of one of the 8 clinical sites participating in the UH3 phase of the ECHO and DINE studies and whose parents had consented to participate in one of the 4 extent cohorts of the following NIH-supported studies: Prematurity and Respiratory Outcomes Program (PROP), the Trial of Late Surfactant (TOLSURF), the NICU Hospital Exposures and Long-Term Health (NICU-HEALTH) study and the Preterm Erythropoietin Neuroprotection Trial (PENUT) study and agreed to longitudinal follow up of infants as part of DINE
Key inclusion criteria (4 listed)
- Children who were study participants in one of the four extant preterm cohorts (PROP, TOLSURF, NICU-HEALTH, and PENUT) that comprise the combined DINE cohort and who were followed to study endpoint at one of the clinical sites in DINE.
- Newly recruited preterm infants admitted to the NICU at the Icahn School of Medicine at Mount Sinai
- Newly recruited preterm and term infants who participated in the PRISM study at University of Rochester
- Parents agreed to be re-contacted or local Institutional Review Board (IRB) grants permission to recontact families to obtain consent to participate in DINE.
Key exclusion criteria (2 listed)
- Family requested that they not be contacted after their child completed the parent study
- Family is unlikely to be available for long-term follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between NICU environmental exposures and lung health and asthma measured by Brief Respiratory Questionnaire
Time frame: One time between the ages of 3 to 4
Brief Respiratory Questionnaire to determine association between exposure and lung health
Associations between NICU environmental exposures and lung health and asthma measured by the PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Asthma Impact item bank
Time frame: One time between the ages of 5 to 6
PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Asthma Impact item bank to determine association between exposure and asthma
Associations between NICU environmental exposures and lung health and asthma measured by PhenX (consensus measures for Phenotypes and eXposures) Toolkit measures of spirometry and bronchodilator responsiveness
Time frame: Twice between the ages of 8 to 12
PhenX (consensus measures for Phenotypes and eXposures) Toolkit measures of spirometry and bronchodilator responsiveness to determine association between exposure and asthma
Associations between NICU environmental exposures and lung health and asthma measured by the PROMIS Pediatric Asthma Impact item bank.
Time frame: Twice between the ages of 8 to 12
PROMIS Pediatric Asthma Impact item bank to determine the association between exposures and asthma
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Early Childhood Cognition Battery
Time frame: Twice within 24 months between the ages of 3 to 5
NIH Toolbox Early Childhood Cognition Battery to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Cognition Battery
Time frame: Twice within 24 months between the ages of 7 to 9
NIH Toolbox Cognition Battery to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Early Childhood Motor Battery
Time frame: Twice within 24 months between the ages of 4 to 6
NIH Toolbox Early Childhood Motor Battery to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by NIH Toolbox Motor Battery
Time frame: Twice between the ages of 8 to 12
NIH Toolbox Motor Battery to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by Child Behavior Checklist (CBCL)
Time frame: One time between the ages of 3 to 4
Child Behavior Checklist (CBCL) to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by PROMIS Cognitive Item bank
Time frame: Three times between the ages of 5 to 12
PROMIS Cognitive Item bank to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by PROMIS Pediatric Mobility Item bank
Time frame: Three times between the ages of 5 to 12
PROMIS Pediatric Mobility Item bank to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and neurocognitive behavioral development measured by PROMIS Pediatric Upper Extremity Item bank
Time frame: Three times between the ages of 5 to 12
PROMIS Pediatric Upper Extremity Item to determine the associations between exposures and neurocognitive behavioral development
Associations between NICU environmental exposures and growth and obesity as measured by height, weight, head circumference, mid-upper arm circumference and bioimpedence
Time frame: Annually, up to 12 years
Measurement of height, weight, head circumference, mid-upper arm circumference and bioimpedence scale to determine associations between exposures and heathy growth and obesity
Associations between NICU environmental exposures and growth and obesity as measured by parent report height and weight
Time frame: Annually, up to 12 years
Parent reported height and weight to determine associations between exposures and healthy growth and obesity
Associations between NICU environmental exposures and pubertal development measured by PhenX Assessment of Pubertal Development
Time frame: Annually, up to 12 years
PhenX Assessment of Pubertal Development to determine associations between exposures and pubertal development
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 28947055Aschner JL, Bancalari EH, McEvoy CT. Can We Prevent Bronchopulmonary Dysplasia? J Pediatr. 2017 Oct;189:26-30. doi: 10.1016/j.jpeds.2017.08.005. No abstract available.
- Background: PubMed 29406438Wright RO, Teitelbaum S, Thompson C, Balshaw D; CHEAR Network. The child health exposure analysis resource as a vehicle to measure environment in the environmental influences on child health outcomes program. Curr Opin Pediatr. 2018 Apr;30(2):285-291. doi: 10.1097/MOP.0000000000000601.
- Background: PubMed 33947953Zhang X, Smith N, Spear E, Stroustrup A. Neighborhood characteristics associated with COVID-19 burden-the modifying effect of age. J Expo Sci Environ Epidemiol. 2021 May;31(3):525-537. doi: 10.1038/s41370-021-00329-1. Epub 2021 May 4.
- Results publication: PubMed 29059271Stroustrup A, Teitelbaum SL, Aschner JL. The Value of Preterm Infant Environmental Health Cohorts: The Canary in the Coal Mine. JAMA Pediatr. 2017 Dec 1;171(12):1139-1140. doi: 10.1001/jamapediatrics.2017.3230. No abstract available.
- Results publication: PubMed 29505594Stroustrup A, Bragg JB, Andra SS, Curtin PC, Spear EA, Sison DB, Just AC, Arora M, Gennings C. Neonatal intensive care unit phthalate exposure and preterm infant neurobehavioral performance. PLoS One. 2018 Mar 5;13(3):e0193835. doi: 10.1371/journal.pone.0193835. eCollection 2018.
- Results publication: PubMed 30242269Stroustrup A, Bragg JB, Busgang SA, Andra SS, Curtin P, Spear EA, Just AC, Arora M, Gennings C. Sources of clinically significant neonatal intensive care unit phthalate exposure. J Expo Sci Environ Epidemiol. 2020 Jan;30(1):137-148. doi: 10.1038/s41370-018-0069-2. Epub 2018 Sep 21.
- Results publication: PubMed 31462446Conradt E, Flannery T, Aschner JL, Annett RD, Croen LA, Duarte CS, Friedman AM, Guille C, Hedderson MM, Hofheimer JA, Jones MR, Ladd-Acosta C, McGrath M, Moreland A, Neiderhiser JM, Nguyen RHN, Posner J, Ross JL, Savitz DA, Ondersma SJ, Lester BM. Prenatal Opioid Exposure: Neurodevelopmental Consequences and Future Research Priorities. Pediatrics. 2019 Sep;144(3):e20190128. doi: 10.1542/peds.2019-0128.
- Results publication: PubMed 31649277Tylavsky FA, Ferrara A, Catellier DJ, Oken E, Li X, Law A, Dabelea D, Rundle A, Gilbert-Diamond D, Hivert MF, Breton CV, Cassidy-Bushrow AE, Mueller NT, Hunt KJ, Arteaga SS, Lombo T, Mahabir S, Ruden D, Sauder K, Hedderson MM, Zhu Y, Polk S, Mihalopoulos NL, Vos M, Pyles L, Roary M, Aschner J, Karagas MR, Trasande L. Understanding childhood obesity in the US: the NIH environmental influences on child health outcomes (ECHO) program. Int J Obes (Lond). 2020 Mar;44(3):617-627. doi: 10.1038/s41366-019-0470-5. Epub 2019 Oct 24.
- Results publication: PubMed 31847006Pourkaviani S, Zhang X, Spear EA, D'Agostino M, Satty RE, Liu SH, Stroustrup A. Clinical validation of the Neonatal Infant Stressor Scale with preterm infant salivary cortisol. Pediatr Res. 2020 Jun;87(7):1237-1243. doi: 10.1038/s41390-019-0713-0. Epub 2019 Dec 17.
- Results publication: PubMed 31772104Stroustrup A, Bragg JB, Spear EA, Aguiar A, Zimmerman E, Isler JR, Busgang SA, Curtin PC, Gennings C, Andra SS, Arora M. Cohort profile: the Neonatal Intensive Care Unit Hospital Exposures and Long-Term Health (NICU-HEALTH) cohort, a prospective preterm birth cohort in New York City. BMJ Open. 2019 Nov 25;9(11):e032758. doi: 10.1136/bmjopen-2019-032758.
- Results publication: PubMed 33993167Faro EZ, Sauder KA, Anderson AL, Dunlop AL, Kerver JM, McGrath M, Roary M, Roman CW, Weidinger C, Huddleston KC. Characteristics of Environmental influences on Child Health Outcomes (ECHO) Cohorts Recruited During Pregnancy. MCN Am J Matern Child Nurs. 2021 Jul-Aug 01;46(4):230-235. doi: 10.1097/NMC.0000000000000725.
- Results publication: PubMed 32526495Schantz SL, Eskenazi B, Buckley JP, Braun JM, Sprowles JN, Bennett DH, Cordero J, Frazier JA, Lewis J, Hertz-Picciotto I, Lyall K, Nozadi SS, Sagiv S, Stroustrup A, Volk HE, Watkins DJ; program collaborators for Environmental influences on Child Health Outcomes. A framework for assessing the impact of chemical exposures on neurodevelopment in ECHO: Opportunities and challenges. Environ Res. 2020 Sep;188:109709. doi: 10.1016/j.envres.2020.109709. Epub 2020 May 23.
- NIH Environmental influences on Child Health Outcomes (ECHO) ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No. All efforts, within reason, are made to keep protected health information (PHI) private, including data gathered for research studies. Using or sharing ("disclosure") such data must follow federal privacy rules. All PHI about children in the study will be entered into REDCap, a secure, web-based data collection platform. Study patients will be identified only by a study identification (ID) number. Access to the REDCap study database is restricted to study personnel, password protected and behind a Medical Center firewall. The study child's name and medical record number will appear only on the Screening Log which contains no other PHI. Only the study team will have access to the Screening Log.
Related trials for Prematurity
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy L Aschner, MD principal investigator
Albert Einstein College of Medicine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by Albert Einstein College of Medicine at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between NICU environmental exposures and lung health and asthma measured by Brief Respiratory Questionnaire (time frame: One time between the ages of 3 to 4). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061890, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.