Nursing and Nurturing Premature Infants

Infant Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388141
• Other study ID #: 2005 0149
• Secondary ID: NIDCAP, HAAG
• Status: Completed
• Phase: Phase 0
• First received: October 12, 2006
• Last updated: November 30, 2007
• Start date: March 2005
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• Premature infants

• The infants' biological mothers

Exclusion Criteria:

• Premature infants with chromosomal anomaly

• Mothers who cannot read and understand Danish

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infant Growth
• Mothers' Parental Competence

Intervention

Behavioral:
• NIDCAP
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

Locations

Country	Name	City	State
Denmark	Faculty of Health Science, University of Aarhus	Aarhus	Jylland

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mothers' self reported experiences of self esteem and social support		18 months
Secondary	Infant growth		18 months
Secondary	Time of discharge		18 months
Secondary	Days of needing oxygen and respiratory support		18 months