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Nursing and Nurturing Premature Infants

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ClinicalTrials.gov Identifier: NCT00388141
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : December 3, 2007
Sponsor:
Collaborators:
Aarhus University Hospital
Novo Nordisk A/S
Information provided by:
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Infant Growth Mothers' Parental Competence Behavioral: NIDCAP Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2005
Study Completion Date : June 2007

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



Primary Outcome Measures :
  1. The mothers' self reported experiences of self esteem and social support [ Time Frame: 18 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00388141     History of Changes
Other Study ID Numbers: 2005 0149
NIDCAP, HAAG
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: December 3, 2007
Last Verified: November 2007

Keywords provided by University of Aarhus:
Preterm Infant;
NIDCAP;
Neonatal Care,
Intervention Study;
Growth and Development;
Maternal Self-esteem.
Maternal Social support
NICU