Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00795990

Enrollment

350

Registered

2008-11-24

Start date

2008-11-30

Completion date

2014-11-30

Last updated

2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Keywords

Efficacy of early vs late use of ibuprofen for PDA closure

Brief summary

Detailed description

This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1. All infants born less than 1200 gms will be evaluated for whether or not an echocardiogram was done. If an echocardiogram was done that showed a PDA, data will be collected as to what medical interventions were done, at what age, and what were the results of the medical intervention. Infants will be stratified into birthweights \<800 gm and 800-1200 gm.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

Healthy volunteers

Inclusion criteria

* birth weight less than 1200 gm

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Early versus Late Medical Treatment of PDA	1 month	The primary objective is to compare early (day of life 4 or less) versus late (day of life 5) medical treatment of PDA. Data will be collected via a retrospective chart review. Information will be collected on both the use of indomethacin and ibuprofen. Both medications are used as standard of care in the NICU for closure of PDAs.

Countries

United States

Outcome results