NCT01029665

Brief Summary

The primary objective of this study is to determine the medical and neurodevelopmental outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years) follow-up. It is generally assumed that older CDH survivors have normal daily function and are able to live normal lives, but this has not been adequately studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 12, 2024

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

November 19, 2009

Last Update Submit

April 11, 2024

Conditions

Hernia, Diaphragmatic

Keywords

Hernia, DiaphragmaticAsthmaFeeding and Eating Disorders of ChildhoodGrowth & Development

Outcome Measures

Primary Outcomes (1)

  • Persistent medical morbidities and/or neurodevelopmental impairment at school age (ages 4-6).

    Visit 1

Study Arms (1)

CDH survivors

School age (ages 4-6) Congenital Diaphragmatic Hernia survivors treated at Duke University Medical Center.

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants with Congenital Diaphragmatic Hernia (CDH) born between 2001 and 2005 who were managed at Duke University Medical Center will be eligible for inclusion in the study.

You may not qualify if:

  • Spanish-speaking only children and families.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hernia, DiaphragmaticAsthmaFeeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Internal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesFeeding and Eating DisordersMental Disorders

Study Officials

  • Jennifer R Benjamin, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

December 10, 2009

Study Start

September 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2010

Last Updated

April 12, 2024

Record last verified: 2013-03

Locations

US(1)