Premature BirthNCT00245843
Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants in the First Year of Life
A study testing Mother Infant Transaction Program (MITP) in people with Premature Birth, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to investigate if the effects of the Vermont intervention, implemented by nurses in a Neonatal Intensive Care Unit (NICU), can influence social interaction and joint attention skills between parents and preterm babies in the second half of the first year of life. Read more about this study
- Who is it for?
- Ages 30 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Mother Infant Transaction Program (MITP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Feb 2010
- Phase
- Interventional
- 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 30 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preterm newborns with gestational age > 29.6 and < 36.0 weeks at birth.
- Full term newborns with gestational age > 36.9 weeks at birth and birth weight equal to or more than 2500 grams
- Admitted to Ullevål University Hospital
- Families are recruited to the study before infants are discharged from the hospital
Who cannot join
- Congenital or chromosomal abnormality, and/or severe neonatal diseases
- History of maternal substance or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants Int the First Year of Life
The purpose of this study is to investigate if the effects of the Vermont intervention, implemented by nurses in a Neonatal Intensive Care Unit (NICU), can influence social interaction and joint attention skills between parents and preterm babies in the second half of the first year of life.
Read the detailed description
The bases of parental sensitivity and infants' joint attention skills are probably established during the child's first year of life. Research suggests that the quality of early social interaction is related to children's later development and mental health. Preterm infants are at risk for developing interaction disturbances in the first year of life, and such aberrancies often lay the foundation for later problems of adaptation. Following preterm birth the infant is exposed to an atypical extra uterine environment. In such an environment it is hard for an immature brain to modulate the infant's behaviour properly.
Under such circumstances there are several factors to consider. The disturbances that may be seen later may be mediated and moderated by the infant's state, parental circumstances and conditions in the hospital environment. Parents of preterm infants experience interruption of normal pregnancy and may be in a difficult emotional state after preterm birth, and often they are not prepared for their role as parents. They are also vulnerable to stress and worries concerning survival of their baby. These conditions are assumed to have a negative influence on the social interaction between preterm infant and parents, and can make it difficult for the caretakers to adapt to their low birth weight infant and to engage in social interaction with their baby.
The purpose of this study is to evaluate the effects of a neonatal intervention program (Vermont-intervention) on parental sensitivity and the interaction skills between parents and preterm babies in the first year of life. The intervention is based on a transactional model of development, which emphasizes the mutual regulation and interaction going on between a child and its caretakers over time.
The study is a randomized controlled trial in a NICU environment. 100 preterm children born between 30 and 36 weeks of gestation are randomly assigned to a control group and an experimental group. The intervention is the Mother Infant Transaction Program (MITP) called the Vermont intervention. In addition, 50 full term normal-weight infants are recruited into a full term control group. The work of recruitment and randomizing of the 150 families to the three groups is carried out by a paediatric research assistant who will also be responsible for the organization and implementation of the interventions at hospital and at home after discharge from hospital. To the extent it is possible, the nurse researcher is not supposed to recognize the group identity of the participants in the three groups when administering questionnaires and scoring video recordings of social interaction and joint attention between mother and child at ages 6, 9 and 12 months.
- Conditions
- Premature Birth
- Being tested
- Mother Infant Transaction Program (MITP)
- Keywords
- Premature birth, moderate preterm, late preterm, Joint attention, Social interaction, Child development, Parent, infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother Infant Transaction Program (MITP)Behavioural
Psychosocial intervention. 11-session one hour standardized intervention program. The aim of the MITP is to help parents to appreciate their infant's unique characteristics,temperament and developmental potential.
What is being measured
The primary outcome is the main question the study is designed to answer.
Social interaction and joint attention skills between parents and moderate/late preterm infants within first year of life
Measured: 1, 4, 6, 9 and 12 months
Child outcome: child's quality and social capacity for joint attention/social interaction
Measured: 1,4, 9 and 12 months
Parenting outcome: parents' sensitivity/responsitivity to children's behaviour/signals, parental stress
Measured: 1, 4, 6, 9 and 12 months
Secondary outcomes (2)
Child outcomes: child development, child temperament, growth
Measured: 1, 4, 6, 9 and 12 months
Parenting outcome: depression, stress, maternal confidence
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionFeb 2008
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse, Norwegian Nurses Association (NSF), University of Oslo
- Investigators
- Rolf Lindemann, MD, PhD, Study director, Ullevål University Hospital (UUS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245843
- Sponsor's protocol ID
- Vermont
- Status last verified
- Mar 2009
- First submitted
- 27 Oct 2005
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ravn IH, Smith L, Smeby NA, Kynoe NM, Sandvik L, Bunch EH, Lindemann R. Effects of early mother-infant intervention on outcomes in mothers and moderately and late preterm infants at age 1 year: a randomized controlled trial. Infant Behav Dev. 2012 Feb;35(1):36-47. doi: 10.1016/j.infbeh.2011.09.006. Epub 2011 Oct 22.
PubMed 22024475Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.
PubMed 21371754
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants Int the First Year of Life
- ClinicalTrials.gov ID
- NCT00245843
- Acronym / sponsor ID
- Vermont
- Conditions
- Premature Birth
- Keywords
- Premature birth, moderate preterm, late preterm, Joint attention, Social interaction, Child development, Parent, infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse, Norwegian Nurses Association (NSF), University of Oslo
- Study start
- Jan 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2010 (estimated)
- First posted
- 28 Oct 2005 (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 the effects of the Vermont intervention, implemented by nurses in a Neonatal Intensive Care Unit (NICU), can influence social interaction and joint attention skills between parents and preterm babies in the second half of the first year of life.
Detailed description
The bases of parental sensitivity and infants' joint attention skills are probably established during the child's first year of life. Research suggests that the quality of early social interaction is related to children's later development and mental health. Preterm infants are at risk for developing interaction disturbances in the first year of life, and such aberrancies often lay the foundation for later problems of adaptation. Following preterm birth the infant is exposed to an atypical extra uterine environment. In such an environment it is hard for an immature brain to modulate the infant's behaviour properly.
Under such circumstances there are several factors to consider. The disturbances that may be seen later may be mediated and moderated by the infant's state, parental circumstances and conditions in the hospital environment. Parents of preterm infants experience interruption of normal pregnancy and may be in a difficult emotional state after preterm birth, and often they are not prepared for their role as parents. They are also vulnerable to stress and worries concerning survival of their baby. These conditions are assumed to have a negative influence on the social interaction between preterm infant and parents, and can make it difficult for the caretakers to adapt to their low birth weight infant and to engage in social interaction with their baby.
The purpose of this study is to evaluate the effects of a neonatal intervention program (Vermont-intervention) on parental sensitivity and the interaction skills between parents and preterm babies in the first year of life. The intervention is based on a transactional model of development, which emphasizes the mutual regulation and interaction going on between a child and its caretakers over time.
The study is a randomized controlled trial in a NICU environment. 100 preterm children born between 30 and 36 weeks of gestation are randomly assigned to a control group and an experimental group. The intervention is the Mother Infant Transaction Program (MITP) called the Vermont intervention. In addition, 50 full term normal-weight infants are recruited into a full term control group. The work of recruitment and randomizing of the 150 families to the three groups is carried out by a paediatric research assistant who will also be responsible for the organization and implementation of the interventions at hospital and at home after discharge from hospital. To the extent it is possible, the nurse researcher is not supposed to recognize the group identity of the participants in the three groups when administering questionnaires and scoring video recordings of social interaction and joint attention between mother and child at ages 6, 9 and 12 months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 30 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Preterm newborns with gestational age > 29.6 and < 36.0 weeks at birth.
- Full term newborns with gestational age > 36.9 weeks at birth and birth weight equal to or more than 2500 grams
- Admitted to Ullevål University Hospital
- Families are recruited to the study before infants are discharged from the hospital
Key exclusion criteria (2 listed)
- Congenital or chromosomal abnormality, and/or severe neonatal diseases
- History of maternal substance or psychiatric disorders.
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 |
|---|---|---|
| Mother Infant Transaction Program (MITP)Psychosocial intervention. 11-session one hour standardized intervention program. The aim of the MITP is to help parents to appreciate their infant's unique characteristics,temperament and developmental potential. | Behavioural | – |
Primary outcome
Social interaction and joint attention skills between parents and moderate/late preterm infants within first year of life
Time frame: 1, 4, 6, 9 and 12 months
Child outcome: child's quality and social capacity for joint attention/social interaction
Time frame: 1,4, 9 and 12 months
Parenting outcome: parents' sensitivity/responsitivity to children's behaviour/signals, parental stress
Time frame: 1, 4, 6, 9 and 12 months
2 secondary outcomes
Child outcomes: child development, child temperament, growth
Time frame: 1, 4, 6, 9 and 12 months
Parenting outcome: depression, stress, maternal confidence
Time frame: 1, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Derived from this study: PubMed 22024475Ravn IH, Smith L, Smeby NA, Kynoe NM, Sandvik L, Bunch EH, Lindemann R. Effects of early mother-infant intervention on outcomes in mothers and moderately and late preterm infants at age 1 year: a randomized controlled trial. Infant Behav Dev. 2012 Feb;35(1):36-47. doi: 10.1016/j.infbeh.2011.09.006. Epub 2011 Oct 22.
- Derived from this study: PubMed 21371754Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.
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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.
Rolf Lindemann, MD, PhD study director
Ullevål University Hospital (UUS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother Infant Transaction Program (MITP) in people with Premature Birth, run by Ullevaal University Hospital at 1 site in Norway.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Apr 2009. 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 Norway. 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.
Are results available for this study?
Results are not available in the source record.
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?
Social interaction and joint attention skills between parents and moderate/late preterm infants within first year of life (time frame: 1, 4, 6, 9 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00245843, which also lists 2 linked publications.
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 1 Apr 2009.