Recruiting
Phase 2

Observational Study

Sponsor:

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

Code:

NCT00166660

Conditions

Preterm Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NIDCAP (Newborn Individualized Developmental Care)

Study Details

Brief summary:

The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity).

Conditions

Preterm Birth

Study ID

NCT00166660

Start date

Jul, 2004

Status verified date

Mar, 2009

Completion date

Jun, 2009

Anticipated

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inborn at Brigham and Women's Hospital, Boston
  • Gestational age ≥28 and ≤33 weeks
  • Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity
  • Less than 5th percentile in birthweight and head circumference for gestational age

Exclusion Criteria:

  • Major chromosomal or congenital anomalies
  • Major congenital infections
  • Significant prenatal diagnosed focal brain lesions
  • Uncontrolled maternal illness
  • History of smoking, alcoholism, and use of illicit drugs
  • History of significant maternal deprivation, abuse, or malnutrition
  • No telephone access and/or insufficient English language facility

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

NIDCAP (Newborn Individualized Developmental Care)

The NIDCAP 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 the 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 formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.

Primary outcome measure

  • Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 2 weeks corrected age (2w CA) ]
  • Quantified Electroencephalography (qEEG) [ Time Frame: 2 weeks Corrected Age (2w CA) ]
  • Magnetic Resonance Imaging(MRI) [ Time Frame: 2 weeks Corrected Age (2w CA) ]

Central Contacts and Locations

Central contacts

Heidelise Als, PhD

617-355-8249heidelise.Als@childrens.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Heidelise Als, PhD

617-355-8249heidelise.als@childrens.harvard.edu

Principal Investigator:

Simon Warfield, PhD

Children's Hospital Boston

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Heidelise Als, PhD

617-355-8249heidelise.als@childrens.harvard.edu

More Information

Sponsor

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

Last update posted

Apr 3, 2009

Last verified

Mar, 2009

Keywords

  • Preterm infants
  • Developmental Care
  • NIDCAP
  • Fetal Growth Restriction
  • Neurobehavior
  • APIB
  • MRI
  • EEG
  • Parent Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2009-04-03.