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Clinical Trials/NCT00388141
NCT00388141
Completed
Early Phase 1

Nursing and Nurturing Premature Infants. An Intervention Study Investigating Systematic Use of Newborn Individualized Developmental Care Assessment Program NIDCAP® Improves Development of Infants and the Mothers' Parental Competence

University of Aarhus1 site in 1 country90 target enrollmentMarch 2005

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Infant Growth
Sponsor
University of Aarhus
Enrollment
90
Locations
1
Primary Endpoint
The mothers' self reported experiences of self esteem and social support
Status
Completed
Last Updated
18 years ago

Overview

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.

Detailed Description

Background: The unborn infant's brain is growing from the fifth month of fetal life which makes preterm babies sensitive to environmental influence. Therefore, to prevent developmental brain injury is an essential goal for neonatal nurses. Purpose: The study investigates whether systematic use of Newborn Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurological development of preterm babies and the parental competence of mothers. Design: This study compares postnatal care of preterm babies in two neonatal units. Participants: Preterm infants born before 32 weeks' gestational age and their mothers. Instruments: * Preterm babies' behaviour in intervention and control groups is observed every 7-12 days using scoring sheets. * Questionnaires focusing on maternal self esteem when the baby is 4 weeks and again at 3 and 18 months and 5 years. Expected outcomes: * Infants: less time with treatment using CPAP and oxygen, growth, time of discharge and pattern of motor behaviour. * Mothers: self reported experiences of self esteem. Analysis: t-test Expected implications: In a health promotion perspective the systematic NIDCAP program hopefully will constitute a more competent mother, knowledgeable in child care and parental management. The intervention NIDCAP®-care infant group is expected to increase in growth compared to the control group, their motor system will be more mature, and there will be an earlier discharge, all factors contributing positively to health economy.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
June 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Premature infants
  • The infants' biological mothers

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 18 months

Secondary Outcomes

  • Infant growth(18 months)
  • Time of discharge(18 months)
  • Days of needing oxygen and respiratory support(18 months)

Study Sites (1)

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