Improving Brain Development in Medically Healthy Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065364
First received: July 21, 2003
Last updated: June 23, 2005
Last verified: October 2004
  Purpose

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.


Condition Intervention
Premature Birth
Behavioral: Newborn Individualized Developmental Care Assessment Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Neurodevelopment and Experience: Behavior, Quantitative EEG and MRI

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • neurodevelopmental function
  • EEG
  • MRI

Estimated Enrollment: 90
Study Start Date: May 2000
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).

  Eligibility

Ages Eligible for Study:   28 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Preterm Infants

  • 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
  • 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

Exclusion Criteria for Preterm Infants

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065364

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Heidelise Als, PhD Harvard University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065364     History of Changes
Other Study ID Numbers: R01HD38261
Study First Received: July 21, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Preterm infant
Premature infant
Developmental care
MRI
qEEG
Neurodevelopment
Behavior
Infants
NICU

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 30, 2014