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Completed

NCT Number: NCT00388141

Nursing and Nurturing Premature Infants

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.

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Key information

Age range

7 day–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Health Science, University of Aarhus

Aarhus, Jylland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature infants
  • The infants' biological mothers

Exclusion criteria

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

Treatment and study plan

NIDCAP

Behavioral

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

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

  1. Infant growth

    Time frame: 18 months

  2. Time of discharge

    Time frame: 18 months

  3. Days of needing oxygen and respiratory support

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Novo Nordisk A/S

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Oct 13, 2006
Registry last updated
Dec 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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