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

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ClinicalTrials.gov Identifier: NCT00914108
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : June 4, 2009
Sponsor:
Information provided by:
Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Intrauterine Growth Retardation Prematurity Behavioral: Newborn Individualized Developmental Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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
Study Start Date : October 1996
Actual Primary Completion Date : July 2000
Actual Study Completion Date : July 2002

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


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 36 Weeks   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914108


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

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
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by Boston Children’s Hospital:
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