Nursing and Nurturing Premature Infants - Full Text View

Sponsors and Collaborators:	University of Aarhus Aarhus University Hospital Novo Nordisk
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00388141

Purpose

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.

Condition	Intervention	Phase
Infant Growth Mothers' Parental Competence	Behavioral: NIDCAP	Phase 0

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Parallel Assignment
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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

The mothers' self reported experiences of self esteem and social support [ Time Frame: 18 months ]

Secondary Outcome Measures:

Infant growth [ Time Frame: 18 months ]
Time of discharge [ Time Frame: 18 months ]
Days of needing oxygen and respiratory support [ Time Frame: 18 months ]

Enrollment:	90
Study Start Date:	March 2005
Study Completion Date:	June 2007

Arms	Assigned Interventions
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 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

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.

Eligibility

Ages Eligible for Study:	up to 32 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Premature infants
The infants' biological mothers

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388141

Locations

Denmark, Jylland
Faculty of Health Science, University of Aarhus
Aarhus, Jylland, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Novo Nordisk

Investigators

Study Chair:	Elisabeth OC Hall, Dr. med. PhD	University of Aarhus
Principal Investigator:	Tine B Henriksen, MD, PhD	University of Aarhus

More Information

Study ID Numbers:	2005 0149, NIDCAP, HAAG
Study First Received:	October 12, 2006
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00388141
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:

Preterm Infant;
NIDCAP;
Neonatal Care,
Intervention Study;

Growth and Development;
Maternal Self-esteem.
Maternal Social support
NICU

ClinicalTrials.gov processed this record on January 16, 2009