Nursing and Nurturing Premature Infants | NCT00388141

Studies
Nursing and Nurturing Premature Infants

NCT00388141

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 3, 2007Estimated

Enrollment

90Actual

Phase

Early Phase 1

Conditions

Infant Growth
Mothers' Parental Competence

Interventions

NIDCAP

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIDCAP, HAAG

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

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Oct 12, 2006

First Submission Date that Met QC Criteria

Oct 12, 2006

First Posted Date

Oct 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2007

Last Update Posted Date

Dec 3, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of AarhusOTHER

Collaborators

Name	Class
Aarhus University Hospital	OTHER
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Behavioral: NIDCAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIDCAP	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The mothers' self reported experiences of self esteem and social support		18 months

Secondary Outcomes

Measure	Description	Time Frame
Infant growth		18 months
Time of discharge		18 months
Days of needing oxygen and respiratory support

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premature infants
The infants' biological mothers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Days

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisabeth OC Hall, Dr. med. PhD	University of Aarhus	Study Chair
Tine B Henriksen, MD, PhD	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Health Science, University of Aarhus		Aarhus	Jylland	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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