NCT00747240

Brief Summary

This is a prospective observational study to determine whether there is an association between the presence of platelet-activating factor acetylhydrolase (PAF-AH) gene polymorphisms and the development of chronic lung disease in very low birth wight infants. Infants \< 1500 grams at birth who require mechanical ventilation will be enrolled in the first 5 days of life after obtaining informed consent. A total of 1 ml of blood will be drawn and utilized for isolation of DNA for genotyping and for measurement of PAF-AH activity in serum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2002

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

February 1, 2002

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 12, 2015

Status Verified

July 1, 2014

Enrollment Period

12.8 years

First QC Date

September 3, 2008

Last Update Submit

May 11, 2015

Conditions

Keywords

Ile198ThrAla379ValvariantsPAF-AH

Outcome Measures

Primary Outcomes (1)

  • Incidence of Chronic Lung Disease (CLD) and survival at 36 weeks corrected gestational age (CGA).

    CLD will be defined as an oxygen requirement and abnormal x-ray findings. Investigations will compare outcomes of participants with genotypic variants of PAF-AH and those without known PAF-AH polymorphisms. Also, participant with biochemical evidence of PAF-AH dysregulation will be compared to those with normal PAF-AH protein and PAF concentrations.

    at 36 weeks (CGA)

Secondary Outcomes (1)

  • PAF-AH genotypic and phenotypic status in relation to multiple morbidities associated with prematurity.

    18 months

Eligibility Criteria

AgeUp to 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Eligible Patients Patients hospitalized in the NICU who: 1. weigh ≤ 1500 grams at birth, 2. are enrolled at age ≤ 5 days, 3. require mechanical ventilation or continuous positive airway pressure (CPAP), 4. have parents or guardians that have signed the informed consent document. Excluded Patients Infants with major congenital anomalies will be excluded.

You may qualify if:

  • Patients hospitalized in the NICU who:
  • weigh ≤ 1500 grams at birth,
  • are enrolled at age ≤ 5 days,
  • require mechanical ventilation or continuous positive airway pressure (CPAP),
  • have parents or guardians that have signed the informed consent document.

You may not qualify if:

  • Infants with major congenital anomalies will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84112, United States

Location

Study Officials

  • Christian C Yost, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 5, 2008

Study Start

February 1, 2002

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 12, 2015

Record last verified: 2014-07

Locations