NCT00166660

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 3, 2009

Status Verified

March 1, 2009

Enrollment Period

4.4 years

First QC Date

September 9, 2005

Last Update Submit

April 1, 2009

Conditions

Preterm Birth

Keywords

Preterm infantsDevelopmental CareNIDCAPFetal Growth RestrictionNeurobehaviorAPIBMRIEEGParent Stress

Outcome Measures

Primary Outcomes (3)

  • Assessment of Preterm Infants' Behavior (APIB)

    2 weeks corrected age (2w CA)

  • Quantified Electroencephalography (qEEG)

    2 weeks Corrected Age (2w CA)

  • Magnetic Resonance Imaging(MRI)

    2 weeks Corrected Age (2w CA)

Secondary Outcomes (1)

  • Parent Stress Level

    2 weeks Corrected Age (2w CA)

Interventions

NIDCAP (Newborn Individualized Developmental Care)BEHAVIORAL

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.

Eligibility Criteria

Age28 Weeks - 33 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

  • 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: 15060237BACKGROUND

MeSH Terms

Conditions

Premature BirthFetal Growth Retardation

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Heidelise Als, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidelise Als, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

April 3, 2009

Record last verified: 2009-03

Locations

US(2)