Clinical trial NCT00388141: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Infant Growth
Mothers' Parental Competence
Keywords: Preterm Infant;
NIDCAP;
Neonatal Care,
Intervention Study;
Growth and Development;
Maternal Self-esteem.
Maternal Social support
NICU
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Novo Nordisk A/S
First posted: 2006-10-13
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Premature infants
* The infants' biological mothers

Exclusion Criteria:

* Premature infants with chromosomal anomaly
* Mothers who cannot read and understand Danish

Primary outcomes:
measure: The mothers' self reported experiences of self esteem and social support
timeFrame: 18 months
Secondary outcomes:
measure: Infant growth
timeFrame: 18 months
measure: Time of discharge
timeFrame: 18 months
measure: Days of needing oxygen and respiratory support
timeFrame: 18 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Faculty of Health Science, University of Aarhus
state: Jylland
Study officials:
affiliation: University of Aarhus
name: Elisabeth OC Hall, Dr. med. PhD
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Tine B Henriksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: