Nursing and Nurturing Premature Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Infant Growth; Mothers' Parental Competence
• Intervention / Treatment: Behavioral: NIDCAP

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Premature infants
• The infants' biological mothers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Newborn Individualized Developmental Care Assessment Program; Induvidualized Neonatal Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mothers' self reported experiences of self esteem and social support	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Infant growth	18 months
Time of discharge	18 months
Days of needing oxygen and respiratory support	18 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Novo Nordisk A/S; Aarhus University Hospital
• Investigators: Study Chair: Elisabeth OC Hall, Dr. med. PhD, University of Aarhus; Principal Investigator: Tine B Henriksen, MD, PhD, University of Aarhus

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: October 12, 2006
• First Submitted That Met QC Criteria: October 12, 2006
• First Posted (Estimate): October 13, 2006

Study Record Updates

• Last Update Posted (Estimate): December 3, 2007
• Last Update Submitted That Met QC Criteria: November 30, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: NICU; Preterm Infant;; NIDCAP;; Neonatal Care,; Intervention Study;; Growth and Development;; Maternal Self-esteem.; Maternal Social support
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2005 0149; NIDCAP, HAAG