Nursing and Nurturing Premature Infants

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Novo Nordisk A/S
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00388141
First received: October 12, 2006
Last updated: November 30, 2007
Last verified: November 2007
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Faculty of Health Science, University of Aarhus
Aarhus, Jylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Novo Nordisk A/S
Investigators
Study Chair: Elisabeth OC Hall, Dr. med. PhD University of Aarhus
Principal Investigator: Tine B Henriksen, MD, PhD University of Aarhus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388141     History of Changes
Other Study ID Numbers: 2005 0149, NIDCAP, HAAG
Study First Received: October 12, 2006
Last Updated: November 30, 2007
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 July 23, 2014