Severe Intrauterine Growth Retardation: Developmental Newborn Intensive Care Unit (NICU) Care

NCT00914108 | Completed

• 1 other identifier: X03-10-072R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit from detailed neuropsychological assessment, psychoeducational recommendations and practical guidance for caregiving, as well as formal educational and emotional support for the family and the professional care team. 2) Neuropsychological education and guidance for community-based early intervention providers caring for SGA preterm infants after their discharge is effective in promoting improved outcome.

Conditions

Intrauterine Growth Retardation; Prematurity

Keywords

Preterm Infants; Developmental Care; NIDCAP; Intrauterine Growth Restriction; APIB; EEG; Neurobehavior

Outcome Measures

Primary Outcomes (1)

• Evidence of improved neurodevelopmental and neurophysiological outcome as assessed with: Assessment of Preterm Infants' Behavior (APIB) and electrophysiological (EEG) assessment

  At 2 weeks , 9 months and 24 months corrected age

Interventions

Newborn Individualized Developmental Care BEHAVIORAL

The developmental care model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists observed each infant's behavior throughout hospitalization and to 2 weeks corrected age and formulated descriptive neurobehavioral reports with suggestions to structure caregiving procedures adapted to the infant's sleep/wake cycle and in support of the infant's well-regulated behavioral balance. Parents were supported to care for their infant, encouraged to nurse and hold their infant skin-to-skin, and to cradle them during stressful procedures.

Also known as: NIDCAP

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Inborn at the Brigham and Women's Hospital
• Gestational age \< 36 weeks
• Birthweight \< 5th percentile
• Head circumference at birth \< 5th percentile

You may not qualify if:

• Presence of major chromosomal or congenital anomalies (Down's, Turner's, Klinefelter's Syndrome, etc.)
• Presence of major congenital infections (HIV, TORCH)
• Presence of significant prenatal focal brain lesions (intrauterine infarcts; cystic changes, etc.)
• Presence of major maternal illness (uncontrolled diabetes, active seizure disorder requiring medication during pregnancy, renal transplant), mental and/or emotional impairment (including heroin addiction and documented alcoholism)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• McAnulty G, Duffy FH, Kosta S, Weisenfeld NI, Warfield SK, Butler SC, Alidoost M, Bernstein JH, Robertson R, Zurakowski D, Als H. School-age effects of the newborn individualized developmental care and assessment program for preterm infants with intrauterine growth restriction: preliminary findings. BMC Pediatr. 2013 Feb 19;13:25. doi: 10.1186/1471-2431-13-25.

  PMID: 23421857 DERIVED

• Als H, Duffy FH, McAnulty G, Butler SC, Lightbody L, Kosta S, Weisenfeld NI, Robertson R, Parad RB, Ringer SA, Blickman JG, Zurakowski D, Warfield SK. NIDCAP improves brain function and structure in preterm infants with severe intrauterine growth restriction. J Perinatol. 2012 Oct;32(10):797-803. doi: 10.1038/jp.2011.201. Epub 2012 Feb 2.

  PMID: 22301525 DERIVED

• Als H, Duffy FH, McAnulty GB, Fischer CB, Kosta S, Butler SC, Parad RB, Blickman JG, Zurakowski D, Ringer SA. Is the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) effective for preterm infants with intrauterine growth restriction? J Perinatol. 2011 Feb;31(2):130-6. doi: 10.1038/jp.2010.81. Epub 2010 Jul 22.

  PMID: 20651694 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation; Premature Birth

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Heidelise Als, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: October 1, 1996
• Primary Completion: July 1, 2000
• Study Completion: July 1, 2002
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

US (2)