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Sponsors and Collaborators: |
University of Aarhus Aarhus University Hospital Novo Nordisk |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00388141 |
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 |
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Infant Growth Mothers' Parental Competence |
Behavioral: NIDCAP |
Phase 0 |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Parallel Assignment |
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 |
Enrollment: | 90 |
Study Start Date: | March 2005 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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NIDCAP: Experimental
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
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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
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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:
Expected outcomes:
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.
Ages Eligible for Study: | up to 32 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Jylland | |
Faculty of Health Science, University of Aarhus | |
Aarhus, Jylland, Denmark, 8000 |
Study Chair: | Elisabeth OC Hall, Dr. med. PhD | University of Aarhus |
Principal Investigator: | Tine B Henriksen, MD, PhD | University of Aarhus |
Study ID Numbers: | 2005 0149, NIDCAP, HAAG |
Study First Received: | October 12, 2006 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00388141 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Preterm Infant; NIDCAP; Neonatal Care, Intervention Study; |
Growth and Development; Maternal Self-esteem. Maternal Social support NICU |