Premature Births2007/2/0150NCT00903149
Long-term Effect of The Mother Infant Transaction Program (MITP)
An observational study of Premature Births, run by Ullevaal University Hospital.
Trial summary
The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age. Read more about this study
- Who is it for?
- Ages 35 to 37 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Births
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2012
- Phase
- Observational
- 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 35 to 37 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The cohort is 42 preterm infants in the intervention group, 40 preterm and 40 full term in control groups.
Who may be able to join
- All parents of children who participated in Ravn's RCT and who said yes to be asked for participation in an eventually later study will be asked.
Who cannot join
None listed.
About this study
The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age.
Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment.
Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.
Read the detailed description
A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. The study followed the children for 1 year.
This study is a follow-up to the above mentioned RCT. It investigates whether the effect of the RCT is present at three years corrected age.
The research questions are:
- Can a psychoeducative program like the MITP influence the childrens' development in various aspects?
- How did the MITP influence the parents experience of concern and stress three years later?
- Were there any differences by the groups? a) Preterm intervention group b)Preterm control group c) Full term control group
The questionnaires to be used in this observational study are:
Ages and Stages
- Conditions
- Premature Births
- Keywords
- Premature babies, Social interaction, Psychoeducative intervention, Mother Infant Transaction Program, Three years follow-up, Late preterm, Cognitive development, Social development, Emotional development, Motor development, Children born preterm and their parents
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MITP exposure or not | Mothers of children born preterm and term. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child development
Measured: 36 months
Parenting stress
Measured: Child age 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startJan 2007
- Primary completionFeb 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthsStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Nina Margrethe Kynø, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903149
- Sponsor's protocol ID
- 977468299
- Acronym
- 2007/2/0150
- Status last verified
- Mar 2016
- First submitted
- 6 May 2009
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of The Mother Infant Transaction Program (MITP)
- ClinicalTrials.gov ID
- NCT00903149
- Acronym / sponsor ID
- 2007/2/0150 / 977468299
- Conditions
- Premature Births
- Keywords
- Premature babies, Social interaction, Psychoeducative intervention, Mother Infant Transaction Program, Three years follow-up, Late preterm, Cognitive development, Social development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 May 2009 (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 investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age.
Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment.
Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.
Detailed description
A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. The study followed the children for 1 year.
This study is a follow-up to the above mentioned RCT. It investigates whether the effect of the RCT is present at three years corrected age.
The research questions are:
- Can a psychoeducative program like the MITP influence the childrens' development in various aspects?
- How did the MITP influence the parents experience of concern and stress three years later?
- Were there any differences by the groups? a) Preterm intervention group b)Preterm control group c) Full term control group
The questionnaires to be used in this observational study are:
Ages and Stages
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MITP exposure or not | – | –Mothers of children born preterm and term. |
Who may qualify
- Ages
- 35 to 37 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The cohort is 42 preterm infants in the intervention group, 40 preterm and 40 full term in control groups.
Key inclusion criteria (1 listed)
- All parents of children who participated in Ravn's RCT and who said yes to be asked for participation in an eventually later study will be asked.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child development
Time frame: 36 months
Parenting stress
Time frame: Child age 36 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 30 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Births, run by Ullevaal University Hospital.
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 1 inclusion and 0 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Child development (time frame: 36 months). The study lists 2 primary outcomes in all. 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 30 Mar 2016.