NCT00903149

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

3.1 years

First QC Date

May 6, 2009

Last Update Submit

March 29, 2016

Conditions

Premature Births

Keywords

Premature babiesSocial interactionPsychoeducative interventionMother Infant Transaction ProgramThree years follow-upLate pretermCognitive developmentSocial developmentEmotional developmentMotor developmentChildren born preterm and their parents

Outcome Measures

Primary Outcomes (2)

  • Child development

    36 months

  • Parenting stress

    Child age 36 months

Study Arms (1)

MITP exposure or not

Mothers of children born preterm and term.

Eligibility Criteria

Age35 Months - 37 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The cohort is 42 preterm infants in the intervention group, 40 preterm and 40 full term in control groups.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 18, 2009

Study Start

January 1, 2007

Primary Completion

February 1, 2010

Study Completion

January 1, 2012

Last Updated

March 30, 2016

Record last verified: 2016-03