Infant GrowthEarly Phase 1NCT00388141
Nursing and Nurturing Premature Infants
A Early Phase 1 study testing NIDCAP in people with Infant Growth and Mothers' Parental Competence, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 32 weeks
- Conditions the study is for
- Infant Growth, Mothers' Parental Competence
- What is being tested?
- NIDCAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Jun 2007
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants
- The infants' biological mothers
Who cannot join
- Premature infants with chromosomal anomaly
- Mothers who cannot read and understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Faculty of Health Science, University of Aarhus
Aarhus, Jylland, 8000
About this study
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
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.
Read the 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.
- Conditions
- Infant Growth, Mothers' Parental Competence
- Being tested
- NIDCAP
- Keywords
- Preterm Infant;, NIDCAP;, Neonatal Care,, Intervention Study;, Growth and Development;, Maternal Self-esteem., Maternal Social support, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIDCAPBehavioural
Also called Newborn Individualized Developmental Care Assessment Program, Induvidualized Neonatal Care
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: NIDCAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mothers' self reported experiences of self esteem and social support
Measured: 18 months
Secondary outcomes (3)
Infant growth
Measured: 18 months
Time of discharge
Measured: 18 months
Days of needing oxygen and respiratory support
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startMar 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Novo Nordisk A/S
- Investigators
- Elisabeth OC Hall, Dr. med. PhD, Study chair, University of AarhusTine B Henriksen, MD, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388141
- Sponsor's protocol ID
- 2005 0149
- Other IDs
- NIDCAP, HAAG
- Status last verified
- Nov 2007
- First submitted
- 12 Oct 2006
- Last updated
- 3 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00388141
- Acronym / sponsor ID
- 2005 0149
- Conditions
- Infant Growth, Mothers' Parental Competence
- Keywords
- Preterm Infant;, NIDCAP;, Neonatal Care,, Intervention Study;, Growth and Development;, Maternal Self-esteem., Maternal Social support, NICU
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Novo Nordisk A/S
- Study start
- Mar 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIDCAP | Experimental | Behavioral: NIDCAPIn 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 |
Who may qualify
- Ages
- 7 days to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Premature infants
- The infants' biological mothers
Key exclusion criteria (2 listed)
- Premature infants with chromosomal anomaly
- Mothers who cannot read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIDCAPAlso: Newborn Individualized Developmental Care Assessment Program, Induvidualized Neonatal CareSystematic 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 | Behavioural | NIDCAP |
Primary outcome
The mothers' self reported experiences of self esteem and social support
Time frame: 18 months
3 secondary outcomes
Infant growth
Time frame: 18 months
Time of discharge
Time frame: 18 months
Days of needing oxygen and respiratory support
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth OC Hall, Dr. med. PhD study chair
University of Aarhus
Tine B Henriksen, MD, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NIDCAP in people with Infant Growth and Mothers' Parental Competence, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mothers' self reported experiences of self esteem and social support (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2007.