Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
90 participants
INTERVENTIONAL
2005-03-31
2007-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The infants' biological mothers
Exclusion Criteria
* Mothers who cannot read and understand Danish
7 Days
32 Weeks
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Novo Nordisk A/S
INDUSTRY
University of Aarhus
OTHER
Principal Investigators
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Elisabeth OC Hall, Dr. med. PhD
Role: STUDY_CHAIR
University of Aarhus
Tine B Henriksen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Faculty of Health Science, University of Aarhus
Aarhus, Jylland, Denmark
Countries
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Other Identifiers
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NIDCAP, HAAG
Identifier Type: -
Identifier Source: secondary_id
2005 0149
Identifier Type: -
Identifier Source: org_study_id