PrematurityPROPNCT01435187
Prematurity and Respiratory Outcomes Program (PROP)
An observational study of Prematurity and Respiratory Disease, run by University of Pennsylvania at 13 sites in United States.
Trial summary
In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Prematurity, Respiratory Disease
- How many people
- 835 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2011to Mar 2016
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age
Who may be able to join
- Infants who are less than or equal to 7 days old
- Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days
Who cannot join
- Infants who meet any of the following conditions will be excluded from the PROP cohort:
- The infant is not considered to be viable (decision made not to provide life-saving therapies)
- Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
- Structural abnormalities of the upper airway, lungs or chest wall
- Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
- Family is unlikely to be available for long-term follow-up
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Buffalo
Buffalo, New York, 14260
Cincinnati University Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas, Houston
Houston, Texas, 77030
Indiana University Health/Riley Hospital for Children
Indianapolis, Indiana, 46202
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Alta Bates Summit Medical Center
Oakland, California, 94609
University of Rochester
Rochester, New York, 14642
University of California, San Francisco
San Francisco, California, 94143
Washington Universitiy
St Louis, Missouri, 63130
About this study
Official title: Prematurity and Respiratory Outcomes Program (PROP) Core Database Protocol
In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected age.
This protocol describes a collaboratively developed multicenter study of very preterm infants from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up to 1 year of age, corrected for the degree of prematurity.
Read the detailed description
The primary goal of the PROP studies is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age. An objective and validated measure of pulmonary outcome at 1 year does not currently exist. Some promising measures are in development but not yet ready for use in a multi-center large clinical study.
Moreover, the burden of chronic respiratory illness on the infants and their families is of utmost importance. A composite primary outcome of morbidity that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life has been developed.
Data collection for the outcome assessment will be based on interviews conducted with the infant's main caregiver at 3, 6, 9 and 12 months corrected age. The time frame for data collection is based on questions "since last contact." Numerous epidemiological studies of asthma have used parental or self report of symptoms, physician-diagnosed asthma and allergies, or the use of medications (which may abrogate symptoms) as critical outcomes.
Survey items selected for the determination of the primary outcome will be focused on the following four domains, with any positive response to any element identifying morbidity:
- Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids, methylxanthines, diuretics, pulmonary vasodilators
- Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration
- Symptoms: any wheeze, cough without cold
- Home technology dependence: use of home oxygen, ventilator or continuous positive airway pressure (CPAP or BiPAP) of any duration since last contact
The primary outcome will be dichotomous, and defined as "No substantial post-prematurity respiratory disease" or "Post-prematurity respiratory disease." To be classified as having post-prematurity respiratory disease, infants must have a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews. Quarterly data collection up to 1 year corrected age will allow us to identify phenotypes based on the trajectory of post-prematurity respiratory disease and how these different trajectories predict later lung function and the diagnosis of asthma, if we continue to follow this cohort of children.
During hospitalization, all centers will obtain samples of tracheal aspirate, urine and saliva (for DNA extraction) from enrolled infants. At 36 weeks PMA, infants will have respiratory assessments dependent upon their respiratory status: i) respiratory inductive plethysmography (RIP) assesses alterations in tidal breathing resulting from reduced lung compliance and airway obstruction, ii) and a room air challenge (RAC).
- Conditions
- Prematurity, Respiratory Disease
- Medical subject headings
- Premature Birth, Respiration Disorders
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 |
|---|---|---|
| Infant Pulmonary Function Testing (iPFT) | A standardized method of performing infant PFTs using the raised volume rapid thoracoabdominal compression (RVRTC) technique will be used. This test will be performed on infants at one year (corrected age). The target sample size of 180 studies will represent the largest number of RVRTC PFTs in the preterm population and will enhance study of the relationship between lung function at 1 year of age and clinical and biologic factors associated with respiratory disease. Although the primary PFT measures will be derived from RVRTC, V'maxFRC, respiratory system compliance (Crs) and resistance (Rrs) will also be measured because these can be easily obtained. Crs and Rrs will be obtained using the single breath occlusion method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory morbidity
The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age.
Measured: 1 year (corrected age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Barbara K Schmidt, MD, Principal investigator, University of PennsylvaniaJonas H Ellenberg, PhD, Principal investigator, University of PennsylvaniaGloria S Pryhuber, MD, Principal investigator, University of RochesterAlan H Jobe, MD, PhD, Principal investigator, Cincinnati Childrens HospitalAaron Hamvas, MD, Principal investigator, Washington University School of Medicine / St. Louis Children's HospitalJudy Aschner, MD, Principal investigator, Vanderbilt University School of MedicineRoberta L Keller, MD, Principal investigator, University of California San Francisco/Benioff Children's HospitalJudith Voynow, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435187
- Sponsor's protocol ID
- 813839
- Other IDs
- U01HL101794-02
- Acronym
- PROP
- Status last verified
- Nov 2016
- First submitted
- 14 Sep 2011
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Maitre NL, Ballard RA, Ellenberg JH, Davis SD, Greenberg JM, Hamvas A, Pryhuber GS; Prematurity and Respiratory Outcomes Program. Respiratory consequences of prematurity: evolution of a diagnosis and development of a comprehensive approach. J Perinatol. 2015 May;35(5):313-321. doi: 10.1038/jp.2015.19. Epub 2015 Mar 26.
PubMed 25811285Pryhuber GS, Maitre NL, Ballard RA, Cifelli D, Davis SD, Ellenberg JH, Greenberg JM, Kemp J, Mariani TJ, Panitch H, Ren C, Shaw P, Taussig LM, Hamvas A; Prematurity and Respiratory Outcomes Program Investigators. Prematurity and respiratory outcomes program (PROP): study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States. BMC Pediatr. 2015 Apr 10;15:37. doi: 10.1186/s12887-015-0346-3.
PubMed 25886363Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.
PubMed 26397992Dylag AM, Kopin HG, O'Reilly MA, Wang H, Davis SD, Ren CL, Pryhuber GS. Early Neonatal Oxygen Exposure Predicts Pulmonary Morbidity and Functional Deficits at 1 Year. J Pediatr. 2020 Aug;223:20-28.e2. doi: 10.1016/j.jpeds.2020.04.042.
PubMed 32711747Voynow JA, Fisher K, Sunday ME, Cotten CM, Hamvas A, Hendricks-Munoz KD, Poindexter BB, Pryhuber GS, Ren CL, Ryan RM, Sharp JK, Young SP, Zhang H, Greenberg RG, Herring AH, Davis SD. Urine gastrin-releasing peptide in the first week correlates with bronchopulmonary dysplasia and post-prematurity respiratory disease. Pediatr Pulmonol. 2020 Apr;55(4):899-908. doi: 10.1002/ppul.24665. Epub 2020 Jan 29.
PubMed 31995668Ren CL, Feng R, Davis SD, Eichenwald E, Jobe A, Moore PE, Panitch HB, Sharp JK, Kisling J, Clem C, Kemp JS. Tidal Breathing Measurements at Discharge and Clinical Outcomes in Extremely Low Gestational Age Neonates. Ann Am Thorac Soc. 2018 Nov;15(11):1311-1319. doi: 10.1513/AnnalsATS.201802-112OC.
PubMed 30088802Blaisdell CJ, Troendle J, Zajicek A; Prematurity and Respiratory Outcomes Program. Acute Responses to Diuretic Therapy in Extremely Low Gestational Age Newborns: Results from the Prematurity and Respiratory Outcomes Program Cohort Study. J Pediatr. 2018 Jun;197:42-47.e1. doi: 10.1016/j.jpeds.2018.01.066. Epub 2018 Mar 26.
PubMed 29599068Keller RL, Feng R, DeMauro SB, Ferkol T, Hardie W, Rogers EE, Stevens TP, Voynow JA, Bellamy SL, Shaw PA, Moore PE; Prematurity and Respiratory Outcomes Program. Bronchopulmonary Dysplasia and Perinatal Characteristics Predict 1-Year Respiratory Outcomes in Newborns Born at Extremely Low Gestational Age: A Prospective Cohort Study. J Pediatr. 2017 Aug;187:89-97.e3. doi: 10.1016/j.jpeds.2017.04.026. Epub 2017 May 17.
PubMed 28528221
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prematurity and Respiratory Outcomes Program (PROP) Core Database Protocol
- ClinicalTrials.gov ID
- NCT01435187
- Acronym / sponsor ID
- PROP / 813839
- Conditions
- Prematurity, Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Sep 2011 (estimated)
- 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.
In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected age.
This protocol describes a collaboratively developed multicenter study of very preterm infants from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up to 1 year of age, corrected for the degree of prematurity.
Detailed description
The primary goal of the PROP studies is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age. An objective and validated measure of pulmonary outcome at 1 year does not currently exist. Some promising measures are in development but not yet ready for use in a multi-center large clinical study.
Moreover, the burden of chronic respiratory illness on the infants and their families is of utmost importance. A composite primary outcome of morbidity that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life has been developed.
Data collection for the outcome assessment will be based on interviews conducted with the infant's main caregiver at 3, 6, 9 and 12 months corrected age. The time frame for data collection is based on questions "since last contact." Numerous epidemiological studies of asthma have used parental or self report of symptoms, physician-diagnosed asthma and allergies, or the use of medications (which may abrogate symptoms) as critical outcomes.
Survey items selected for the determination of the primary outcome will be focused on the following four domains, with any positive response to any element identifying morbidity:
- Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids, methylxanthines, diuretics, pulmonary vasodilators
- Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration
- Symptoms: any wheeze, cough without cold
- Home technology dependence: use of home oxygen, ventilator or continuous positive airway pressure (CPAP or BiPAP) of any duration since last contact
The primary outcome will be dichotomous, and defined as "No substantial post-prematurity respiratory disease" or "Post-prematurity respiratory disease." To be classified as having post-prematurity respiratory disease, infants must have a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews. Quarterly data collection up to 1 year corrected age will allow us to identify phenotypes based on the trajectory of post-prematurity respiratory disease and how these different trajectories predict later lung function and the diagnosis of asthma, if we continue to follow this cohort of children.
During hospitalization, all centers will obtain samples of tracheal aspirate, urine and saliva (for DNA extraction) from enrolled infants. At 36 weeks PMA, infants will have respiratory assessments dependent upon their respiratory status: i) respiratory inductive plethysmography (RIP) assesses alterations in tidal breathing resulting from reduced lung compliance and airway obstruction, ii) and a room air challenge (RAC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant Pulmonary Function Testing (iPFT) | – | –A standardized method of performing infant PFTs using the raised volume rapid thoracoabdominal compression (RVRTC) technique will be used. This test will be performed on infants at one year (corrected age). The target sample size of 180 studies will represent the largest number of RVRTC PFTs in the preterm population and will enhance study of the relationship between lung function at 1 year of age and clinical and biologic factors associated with respiratory disease. Although the primary PFT measures will be derived from RVRTC, V'maxFRC, respiratory system compliance (Crs) and resistance (Rrs) will also be measured because these can be easily obtained. Crs and Rrs will be obtained using the single breath occlusion method. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age
Key inclusion criteria (2 listed)
- Infants who are less than or equal to 7 days old
- Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days
Key exclusion criteria (6 listed)
- Infants who meet any of the following conditions will be excluded from the PROP cohort:
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
Respiratory morbidity
Time frame: 1 year (corrected age)
The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age.
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 7 Nov 2016.
- Background: PubMed 25811285Maitre NL, Ballard RA, Ellenberg JH, Davis SD, Greenberg JM, Hamvas A, Pryhuber GS; Prematurity and Respiratory Outcomes Program. Respiratory consequences of prematurity: evolution of a diagnosis and development of a comprehensive approach. J Perinatol. 2015 May;35(5):313-321. doi: 10.1038/jp.2015.19. Epub 2015 Mar 26.
- Background: PubMed 25886363Pryhuber GS, Maitre NL, Ballard RA, Cifelli D, Davis SD, Ellenberg JH, Greenberg JM, Kemp J, Mariani TJ, Panitch H, Ren C, Shaw P, Taussig LM, Hamvas A; Prematurity and Respiratory Outcomes Program Investigators. Prematurity and respiratory outcomes program (PROP): study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States. BMC Pediatr. 2015 Apr 10;15:37. doi: 10.1186/s12887-015-0346-3.
- Background: PubMed 26397992Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.
- Derived from this study: PubMed 32711747Dylag AM, Kopin HG, O'Reilly MA, Wang H, Davis SD, Ren CL, Pryhuber GS. Early Neonatal Oxygen Exposure Predicts Pulmonary Morbidity and Functional Deficits at 1 Year. J Pediatr. 2020 Aug;223:20-28.e2. doi: 10.1016/j.jpeds.2020.04.042.
- Derived from this study: PubMed 31995668Voynow JA, Fisher K, Sunday ME, Cotten CM, Hamvas A, Hendricks-Munoz KD, Poindexter BB, Pryhuber GS, Ren CL, Ryan RM, Sharp JK, Young SP, Zhang H, Greenberg RG, Herring AH, Davis SD. Urine gastrin-releasing peptide in the first week correlates with bronchopulmonary dysplasia and post-prematurity respiratory disease. Pediatr Pulmonol. 2020 Apr;55(4):899-908. doi: 10.1002/ppul.24665. Epub 2020 Jan 29.
- Derived from this study: PubMed 30088802Ren CL, Feng R, Davis SD, Eichenwald E, Jobe A, Moore PE, Panitch HB, Sharp JK, Kisling J, Clem C, Kemp JS. Tidal Breathing Measurements at Discharge and Clinical Outcomes in Extremely Low Gestational Age Neonates. Ann Am Thorac Soc. 2018 Nov;15(11):1311-1319. doi: 10.1513/AnnalsATS.201802-112OC.
- Derived from this study: PubMed 29599068Blaisdell CJ, Troendle J, Zajicek A; Prematurity and Respiratory Outcomes Program. Acute Responses to Diuretic Therapy in Extremely Low Gestational Age Newborns: Results from the Prematurity and Respiratory Outcomes Program Cohort Study. J Pediatr. 2018 Jun;197:42-47.e1. doi: 10.1016/j.jpeds.2018.01.066. Epub 2018 Mar 26.
- Derived from this study: PubMed 28528221Keller RL, Feng R, DeMauro SB, Ferkol T, Hardie W, Rogers EE, Stevens TP, Voynow JA, Bellamy SL, Shaw PA, Moore PE; Prematurity and Respiratory Outcomes Program. Bronchopulmonary Dysplasia and Perinatal Characteristics Predict 1-Year Respiratory Outcomes in Newborns Born at Extremely Low Gestational Age: A Prospective Cohort Study. J Pediatr. 2017 Aug;187:89-97.e3. doi: 10.1016/j.jpeds.2017.04.026. Epub 2017 May 17.
- Individual participant dataSharing planned: Undecided
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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.
Barbara K Schmidt, MD principal investigator
University of Pennsylvania
Jonas H Ellenberg, PhD principal investigator
University of Pennsylvania
Gloria S Pryhuber, MD principal investigator
University of Rochester
13 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 and Respiratory Disease, run by University of Pennsylvania at 13 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 2 inclusion and 6 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Respiratory morbidity (time frame: 1 year (corrected age)). 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 NCT01435187, which also lists 8 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 7 Nov 2016.