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CompletedNCT00388141Updated Dec 3, 2007

Nursing and Nurturing Premature Infants

An Early Phase 1 interventional study of NIDCAP in Infant Growth and Mothers' Parental Competence, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 7 Days to 32 Weeks. Per ClinicalTrials.gov, last updated 2007-12-03.

Sponsored by University of Aarhus · Early Phase 1, Interventional, and Supportive care

Phase
Early Phase 1
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
7 Days to 32 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infant Growth
  • Mothers' Parental Competence

Keywords

  • Preterm Infant;
  • NIDCAP;
  • Neonatal Care,
  • Intervention Study;
  • Growth and Development;
  • Maternal Self-esteem.
  • Maternal Social support
  • NICU
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Days to 32 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Premature infants
  • The infants' biological mothers

Exclusion criteria

Exclusion Criteria:

  • Premature infants with chromosomal anomaly
  • Mothers who cannot read and understand Danish
05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralNIDCAP

    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

    Also known as: Newborn Individualized Developmental Care Assessment Program, Induvidualized Neonatal Care

06

What researchers measure

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

07

Study locations

1 site
  • Faculty of Health Science, University of Aarhus
    Aarhus, Jylland 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00388141
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Novo Nordisk A/S
First posted
Oct 13, 2006
Start date
Mar 2005
Completion
Jun 2007
Last update
Dec 3, 2007

Study contacts

Elisabeth OC Hall, Dr. med. PhD
study chair · University of Aarhus
Tine B Henriksen, MD, PhD
principal investigator · University of Aarhus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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