Premature BirthNCT00065364
Improving Brain Development in Medically Healthy Premature Infants
A study testing Newborn Individualized Developmental Care Assessment Program in people with Premature Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Premature infants born between 28 and 33 weeks' gestation often have significant brain damage. Brain damage can be caused by the much greater stimulation the infant receives in the neonatal intensive care unit (NICU) as compared to the mother's womb. Read more about this study
- Who is it for?
- Ages 28 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Newborn Individualized Developmental Care Assessment Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to not given
- Phase
- Interventional
- 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 28 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at Brigham and Women's Hospital (BWH), Boston
- Family residence in the greater Boston area
- Gestational age at birth of 28 to 33 weeks assessed by mother's dates, the Ballard assessment, and prenatal ultrasound as available
- Birthweight, height, and head circumference appropriate (10th to 90th percentile) for gestational age
- 1 and 5 minute Apgar >= 7
- Endotracheal intubation and mechanical ventilator support, including continuous positive airway pressure (CPAP), for < 48 hours after delivery
Show all 10Show fewer
- Normal cranial ultrasound(s) within first 7 days of life
- Mother between 15 and 39 years old
- Telephone access
- Sufficient English language facility to assure successful communication and follow-up
Who cannot join
- Use of dopamine or hydrocortisone
- Chromosomal or congenital abnormalities (e.g., Down's, Turner's, Klinefelter's syndromes)
- Congenital or acquired infections (e.g., TORCH, HIV, sepsis)
- Major maternal illness; diagnosed mental and/or emotional impairment; reported alcohol, nicotine, or illegal drug use and/or positive urine toxicity screen; or chronic medication treatment (e.g., synthroid, insulin, steroids)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Neurodevelopment and Experience: Behavior, Quantitative EEG and MRI
Premature infants born between 28 and 33 weeks' gestation often have significant brain damage. Brain damage can be caused by the much greater stimulation the infant receives in the neonatal intensive care unit (NICU) as compared to the mother's womb. This study will test the effectiveness of specialized and individualized NICU developmental care in preventing brain damage.
Read the detailed description
From 28 to 33 weeks' gestation, significant neurological reorganization takes place, initiating fetal behavioral individuality and capacity for extrauterine survival. Infants born at this transitional stage exhibit unexpectedly significant brain dysfunction as they develop and age. The majority of these infants will develop psychomotor, cognitive, and attentional function deficits as well as emotional vulnerability and substandard school performance. Research suggests that these symptoms are due to a central deficit in frontal lobe processing of complex information. This central deficit may result from increased vulnerability of cerebral white matter during the last trimester of gestation, its phase of most rapid development. Persistent stress due to inappropriate sensory stimulation may contribute to alteration of early brain structure and function. This study will identify specific adaptations of the preterm brain to the transient NICU experience in order to estimate the potential of such experience in remodeling neuroanatomical structure and neurodevelopmental function. Further, the study will evaluate a program of specialized developmental care within the NICU environment.
The study's specialized developmental care model views the preterm infant as a fetus and attempts to reduce the discrepancy between the technological hospital environment and the mother's womb. A developmental specialist team will support the NICU caregivers. The developmental specialists will observe the infant's behavior and use these observations to formulate descriptive neurobehavioral reports and suggestions, to structure caregiving procedures in coordination with the infant's sleep/wake cycle, and to maintain the infant's well-regulated behavioral balance. The goal of the intervention is to promote the infant's strengths while reducing the infant's self-regulatory vulnerability.
Sixty medically healthy infants born between 28 and 33 weeks' gestation will be randomly assigned to standard NICU care or specialized developmental care. Preterm infants will be compared to 30 healthy full term infants. All infants will be assessed at 42 weeks' postconceptional age in three neurodevelopmental domains: neurobehavioral function, neuroelectrophysiological function, and neuroanatomic structure. Assessments will focus on distinct regions of the brain (occipital and frontal lobes) and the corpus callosum (which connects the right and left sides of the brain).
- Conditions
- Premature Birth
- Being tested
- Newborn Individualized Developmental Care Assessment Program
- Keywords
- Preterm infant, Premature infant, Developmental care, MRI, qEEG, Neurodevelopment, Behavior, Infants, NICU
- Medical subject headings
- Premature Birth, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newborn Individualized Developmental Care Assessment ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
neurodevelopmental function
EEG
MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2003 (estimated)
- Study startMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Heidelise Als, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065364
- Sponsor's protocol ID
- R01HD038261
- Status last verified
- Oct 2004
- First submitted
- 21 Jul 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
PubMed 15060237Rivkin MJ, Wolraich D, Als H, McAnulty G, Butler S, Conneman N, Fischer C, Vajapeyam S, Robertson RL, Mulkern RV. Prolonged T*2 values in newborn versus adult brain: Implications for fMRI studies of newborns. Magn Reson Med. 2004 Jun;51(6):1287-91. doi: 10.1002/mrm.20098.
PubMed 15170852
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopment and Experience: Behavior, Quantitative EEG and MRI
- ClinicalTrials.gov ID
- NCT00065364
- Acronym / sponsor ID
- R01HD038261
- Conditions
- Premature Birth
- Keywords
- Preterm infant, Premature infant, Developmental care, MRI, qEEG, Neurodevelopment, Behavior, Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- May 2000
- First posted
- 23 Jul 2003 (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.
Premature infants born between 28 and 33 weeks' gestation often have significant brain damage. Brain damage can be caused by the much greater stimulation the infant receives in the neonatal intensive care unit (NICU) as compared to the mother's womb. This study will test the effectiveness of specialized and individualized NICU developmental care in preventing brain damage.
Detailed description
From 28 to 33 weeks' gestation, significant neurological reorganization takes place, initiating fetal behavioral individuality and capacity for extrauterine survival. Infants born at this transitional stage exhibit unexpectedly significant brain dysfunction as they develop and age. The majority of these infants will develop psychomotor, cognitive, and attentional function deficits as well as emotional vulnerability and substandard school performance. Research suggests that these symptoms are due to a central deficit in frontal lobe processing of complex information. This central deficit may result from increased vulnerability of cerebral white matter during the last trimester of gestation, its phase of most rapid development. Persistent stress due to inappropriate sensory stimulation may contribute to alteration of early brain structure and function. This study will identify specific adaptations of the preterm brain to the transient NICU experience in order to estimate the potential of such experience in remodeling neuroanatomical structure and neurodevelopmental function. Further, the study will evaluate a program of specialized developmental care within the NICU environment.
The study's specialized developmental care model views the preterm infant as a fetus and attempts to reduce the discrepancy between the technological hospital environment and the mother's womb. A developmental specialist team will support the NICU caregivers. The developmental specialists will observe the infant's behavior and use these observations to formulate descriptive neurobehavioral reports and suggestions, to structure caregiving procedures in coordination with the infant's sleep/wake cycle, and to maintain the infant's well-regulated behavioral balance. The goal of the intervention is to promote the infant's strengths while reducing the infant's self-regulatory vulnerability.
Sixty medically healthy infants born between 28 and 33 weeks' gestation will be randomly assigned to standard NICU care or specialized developmental care. Preterm infants will be compared to 30 healthy full term infants. All infants will be assessed at 42 weeks' postconceptional age in three neurodevelopmental domains: neurobehavioral function, neuroelectrophysiological function, and neuroanatomic structure. Assessments will focus on distinct regions of the brain (occipital and frontal lobes) and the corpus callosum (which connects the right and left sides of the brain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 28 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Born at Brigham and Women's Hospital (BWH), Boston
- Family residence in the greater Boston area
- Gestational age at birth of 28 to 33 weeks assessed by mother's dates, the Ballard assessment, and prenatal ultrasound as available
- Birthweight, height, and head circumference appropriate (10th to 90th percentile) for gestational age
- 1 and 5 minute Apgar >= 7
Key exclusion criteria (4 listed)
- Use of dopamine or hydrocortisone
- Chromosomal or congenital abnormalities (e.g., Down's, Turner's, Klinefelter's syndromes)
- Congenital or acquired infections (e.g., TORCH, HIV, sepsis)
- Major maternal illness; diagnosed mental and/or emotional impairment; reported alcohol, nicotine, or illegal drug use and/or positive urine toxicity screen; or chronic medication treatment (e.g., synthroid, insulin, steroids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newborn Individualized Developmental Care Assessment Program | Behavioural | – |
Primary outcome
neurodevelopmental function
EEG
MRI
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 Jun 2005.
- Background: PubMed 15060237Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
- Background: PubMed 15170852Rivkin MJ, Wolraich D, Als H, McAnulty G, Butler S, Conneman N, Fischer C, Vajapeyam S, Robertson RL, Mulkern RV. Prolonged T*2 values in newborn versus adult brain: Implications for fMRI studies of newborns. Magn Reson Med. 2004 Jun;51(6):1287-91. doi: 10.1002/mrm.20098.
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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.
Heidelise Als, PhD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newborn Individualized Developmental Care Assessment Program in people with Premature Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site 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 10 inclusion and 4 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 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
neurodevelopmental function. The study lists 3 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 NCT00065364, which also lists 2 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 Jun 2005; AzTrials last refreshed its copy on 31 Oct 2026.