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Nursing and Nurturing Premature Infants

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University of Aarhus

Status and phase

Completed
Early Phase 1

Conditions

Mothers' Parental Competence
Infant Growth

Treatments

Behavioral: NIDCAP

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00388141
2005 0149
NIDCAP, HAAG

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

7 days to 32 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Premature infants
  • The infants' biological mothers

Exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 1 patient group

NIDCAP
Experimental group
Description:
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
Treatment:
Behavioral: NIDCAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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