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

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00914108
First received: June 3, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Intrauterine Growth Retardation
Prematurity
Behavioral: Newborn Individualized Developmental Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Centered Neuropsychoeducational In-NICU Intervention for Preterm Infants With Severe Intrauterine Growth Retardation and for Their Families

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Evidence of improved neurodevelopmental and neurophysiological outcome as assessed with: Assessment of Preterm Infants' Behavior (APIB) and electrophysiological (EEG) assessment [ Time Frame: At 2 weeks , 9 months and 24 months corrected age ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 1996
Study Completion Date: July 2002
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Newborn Individualized Developmental Care
    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.
    Other Name: NIDCAP
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914108

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

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heidelise Als, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00914108     History of Changes
Other Study ID Numbers: X03-10-072R
Study First Received: June 3, 2009
Last Updated: June 3, 2009
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Boston:
Preterm Infants
Developmental Care
NIDCAP
Intrauterine Growth Restriction
APIB
EEG
Neurobehavior

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014