Nursing and Nurturing Premature Infants
Primary Purpose
Infant Growth, Mothers' Parental Competence
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
NIDCAP
Sponsored by
About this trial
This is an interventional supportive care trial for Infant Growth focused on measuring Preterm Infant;, NIDCAP;, Neonatal Care,, Intervention Study;, Growth and Development;, Maternal Self-esteem., Maternal Social support, NICU
Eligibility Criteria
Inclusion Criteria:
- Premature infants
- The infants' biological mothers
Exclusion Criteria:
- Premature infants with chromosomal anomaly
- Mothers who cannot read and understand Danish
Sites / Locations
- Faculty of Health Science, University of Aarhus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NIDCAP
Arm 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
Outcomes
Primary Outcome Measures
The mothers' self reported experiences of self esteem and social support
Secondary Outcome Measures
Infant growth
Time of discharge
Days of needing oxygen and respiratory support
Full Information
NCT ID
NCT00388141
First Posted
October 12, 2006
Last Updated
November 30, 2007
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT00388141
Brief Title
Nursing and Nurturing Premature Infants
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 Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Growth, Mothers' Parental Competence
Keywords
Preterm Infant;, NIDCAP;, Neonatal Care,, Intervention Study;, Growth and Development;, Maternal Self-esteem., Maternal Social support, NICU
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIDCAP
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
NIDCAP
Other Intervention Name(s)
Newborn Individualized Developmental Care Assessment Program, Induvidualized Neonatal Care
Intervention Description
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
Primary Outcome Measure Information:
Title
The mothers' self reported experiences of self esteem and social support
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Infant growth
Time Frame
18 months
Title
Time of discharge
Time Frame
18 months
Title
Days of needing oxygen and respiratory support
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature infants
The infants' biological mothers
Exclusion Criteria:
Premature infants with chromosomal anomaly
Mothers who cannot read and understand Danish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth OC Hall, Dr. med. PhD
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tine B Henriksen, MD, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Science, University of Aarhus
City
Aarhus
State/Province
Jylland
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Nursing and Nurturing Premature Infants
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