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
|Condition or disease||Intervention/treatment||Phase|
|Infant Growth Mothers' Parental Competence||Behavioral: NIDCAP||Early Phase 1|
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.
- 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.
- 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|
|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|
|Actual Study Completion Date :||June 2007|
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
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
- The mothers' self reported experiences of self esteem and social support [ Time Frame: 18 months ]
- Infant growth [ Time Frame: 18 months ]
- Time of discharge [ Time Frame: 18 months ]
- Days of needing oxygen and respiratory support [ Time Frame: 18 months ]
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
|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|