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NCT01385254 · ClinicalTrials.gov registry record

Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

A clinical trial of Very Low Birthweight, sponsored by Duke University.

Completed
Registry status
300
Enrollment target
2
Study locations

NCT01385254: Completed study of Very Low Birthweight, sponsored by Duke University.

NCT01385254 is a study of Very Low Birthweight that has completed, run by Duke University. The registered enrollment target is 300 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01385254, a study of Very Low Birthweight, has completed, sponsored by Duke University.

COMPLETED
Registry status
300 participants
Enrollment target
2
Study locations

Study Summary

The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.

Primary Outcome

Explore how the trajectories of maternal worry about the infant and sibling, anxiety, depression, post traumatic stress, concerns for and expectations of the sibling, and perceptions of sibling growth over the 6-month post discharge period differ between mothers of VLBW infants and mothers of fullterms.

Conditions Studied

Study Locations (2)

North Carolina

  • Duke University Medical Center - Durham
  • Wake Medical Center - Raleigh

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2010-01
Est. Completion 2012-10
Duke University

1,725 total trials

What the finished NCT01385254 record still lists

NCT01385254 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Very Low Birthweight appearing as the primary indexed condition, and to 0 interventions.

NCT01385254 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT01385254 about?

NCT01385254 is a clinical study titled "Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming". The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby ...

What is the current status of trial NCT01385254?

This trial is currently completed. The enrollment target is 300 participants. The study started on 2010-01. Estimated completion is 2012-10.

What conditions does trial NCT01385254 study?

This clinical trial studies the following conditions: Very Low Birthweight.

Who is sponsoring clinical trial NCT01385254?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01385254 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01385254, the US trial registry maintained by the National Library of Medicine. NCT01385254 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.