NCT00388141

Brief Summary

The purpose of this study is to determine whether systematic use of the Newborn Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurologic development of children and the parental competence of mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2005

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 3, 2007

Status Verified

November 1, 2007

First QC Date

October 12, 2006

Last Update Submit

November 30, 2007

Conditions

Infant GrowthMothers' Parental Competence

Keywords

Preterm Infant;NIDCAP;Neonatal Care,Intervention Study;Growth and Development;Maternal Self-esteem.Maternal Social supportNICU

Outcome Measures

Primary Outcomes (1)

  • The mothers' self reported experiences of self esteem and social support

    18 months

Secondary Outcomes (3)

  • Infant growth

    18 months

  • Time of discharge

    18 months

  • Days of needing oxygen and respiratory support

    18 months

Study Arms (1)

NIDCAP

EXPERIMENTAL

In the intervention NIDCAP group the staff has been introduced and trained in the principles of the NIDCAP-care, where main core is to see, organize and conduct the care of the preterm infant on behalf of the childs actually resources and competences

Behavioral: NIDCAP

Interventions

NIDCAPBEHAVIORAL

Systematic care, where the mother and the nurses organize the caring on behalf of the preterm infants' ressources and developmental capacity such as the infant avoid over stimulation and distress

Also known as: Newborn Individualized Developmental Care Assessment Program, Induvidualized Neonatal Care
NIDCAP

Eligibility Criteria

Age7 Days - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature infants
  • The infants' biological mothers

You may not qualify if:

  • Premature infants with chromosomal anomaly
  • Mothers who cannot read and understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Science, University of Aarhus

Aarhus, Jylland, 8000, Denmark

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elisabeth OC Hall, Dr. med. PhD

    University of Aarhus

    STUDY CHAIR

  • Tine B Henriksen, MD, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

March 1, 2005

Study Completion

June 1, 2007

Last Updated

December 3, 2007

Record last verified: 2007-11

Locations

DK(1)