Nursing and Nurturing Premature Infants

Early Phase 1

Completed

• Conditions: Infant Growth; Mothers' Parental Competence
• Interventions: Behavioral: NIDCAP

• Registration Number: NCT00388141
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Study Completion: 2007-06
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-30
• Last Update Posted: 2007-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Premature infants
• The infants' biological mothers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIDCAP	NIDCAP	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

Primary Outcome Measures

Name	Time	Method
The mothers' self reported experiences of self esteem and social support	18 months

Secondary Outcome Measures

Name	Time	Method
Infant growth	18 months
Time of discharge	18 months
Days of needing oxygen and respiratory support	18 months

Trial Locations

Locations (1)

Faculty of Health Science, University of Aarhus; 🇩🇰 Aarhus, Jylland, Denmark