NCT00179933

Brief Summary

The purpose of this study is to evaluate the impact of the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU. Behavioral response to routine caregiving will be compared between infants in the pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that will be used to evaluate the effectiveness of the NIDCAP program.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

First QC Date

September 14, 2005

Last Update Submit

November 19, 2024

Conditions

Infant, Premature

Keywords

developmental careNeonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Behavioral function score within 72 hours of admission and Behavioral function score at 34-36 weeks gestation.

Secondary Outcomes (2)

  • Environment and caregiving score within 72 hours of admit

  • Environment and caregiving score at 34-36 weeks gestation

Interventions

Newborn Individualized Assessment ProgramBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • preterm infants born at less than or equal to 32 weeks gestation, appropriate for gestational age in weight

You may not qualify if:

  • congenital or chromosomal abnormality, history of maternal substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Barbara A Fleming, RNC, MS

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist/Educator

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Study Completion

February 1, 2007

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

US(1)