Improving Brain Development in Medically Healthy Premature Infants

NCT00065364 | Completed

• 1 other identifier: R01HD038261
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. This study will test the effectiveness of specialized and individualized NICU developmental care in preventing brain damage.

Conditions

Premature Birth

Keywords

Preterm infant; Premature infant; Developmental care; MRI; qEEG; Neurodevelopment; Behavior; Infants; NICU

Outcome Measures

Primary Outcomes (3)

• neurodevelopmental function

• EEG

• MRI

Interventions

Newborn Individualized Developmental Care Assessment Program BEHAVIORAL

Eligibility Criteria

• Age: 28 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 15060237 BACKGROUND

• Rivkin 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.

  PMID: 15170852 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Heidelise Als, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 21, 2003
• First Posted: July 23, 2003
• Study Start: May 1, 2000
• Last Updated: June 24, 2005

Record last verified: 2004-10

Locations

US (1)