NCT00245843

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

3.1 years

First QC Date

October 27, 2005

Last Update Submit

March 31, 2009

Conditions

Premature Birth

Keywords

Premature birthmoderate pretermlate pretermJoint attentionSocial interactionChild developmentParentinfant

Outcome Measures

Primary Outcomes (3)

  • Social interaction and joint attention skills between parents and moderate/late preterm infants within first year of life

    1, 4, 6, 9 and 12 months

  • Child outcome: child's quality and social capacity for joint attention/social interaction

    1,4, 9 and 12 months

  • Parenting outcome: parents' sensitivity/responsitivity to children's behaviour/signals, parental stress

    1, 4, 6, 9 and 12 months

Secondary Outcomes (2)

  • Child outcomes: child development, child temperament, growth

    1, 4, 6, 9 and 12 months

  • Parenting outcome: depression, stress, maternal confidence

    1, 6 and 12 months

Interventions

Mother Infant Transaction Program (MITP)BEHAVIORAL

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.

Eligibility Criteria

Age30 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Congenital or chromosomal abnormality, and/or severe neonatal diseases
  • History of maternal substance or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital (UUS)

Oslo, 0407, Norway

Location

Related Publications (2)

  • 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.

    PMID: 22024475DERIVED

  • Ravn 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.

    PMID: 21371754DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Rolf Lindemann, MD, PhD

    Ullevål University Hospital (UUS)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

January 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2010

Last Updated

April 1, 2009

Record last verified: 2009-03

Locations

NO(1)