Patent Ductus Arteriosus (PDA) Screening Trial

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by University of Pennsylvania.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01031316

First received: December 1, 2009

Last updated: May 23, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2009

Last Updated Date

May 23, 2011

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of days to regain birth weight. [ Time Frame: 1-4 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01031316 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment for a PDA with indomethacin or surgical ligation. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Number of days to 120ml/kg/day of enteral feedings (full feeds). [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Ventilator days, number of days of positive airway pressure, and number of days in oxygen. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Confirmed or suspected sepsis. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Worst stage of retinopathy of prematurity. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Day of death or discharge. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Patent Ductus Arteriosus (PDA) Screening Trial

Official Title ^ICMJE

The Role of Serial Echocardiography to Detect an Asymptomatic Patent Ductus Arteriosus (PDA) in Very Low Birth Weight (VLBW) Infants: A Pilot Randomized Controlled Trial

Brief Summary

The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). However, this association may not be a causal relationship.

Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.

A randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. The investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Condition ^ICMJE

Ductus Arteriosus, Patent

Intervention ^ICMJE

Other: Nondisclosure of screening echocardiogram results
Subjects will be randomized to nondisclosure of screening echocardiogram results.
Other: Disclosure of screening echocardiogram results
Subjects will be randomized to disclosure of screening echocardiogram results.

Study Arm (s)

Experimental: Nondisclosure
Intervention: Other: Nondisclosure of screening echocardiogram results
No Intervention: Disclosure
Intervention: Other: Disclosure of screening echocardiogram results

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

birth weight less than or equal to 1250 grams
gestational age less than or equal to 30 weeks
postnatal age less than or equal to 72 hours
have a guardian or acceptable surrogate capable of giving consent on his/her behalf

Exclusion Criteria:

not considered viable
dysmorphic features or congenital malformations that adversely affect growth
have known or suspected congenital heart disease (other than PDA)

Gender

Both

Ages

up to 72 Hours

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01031316

Other Study ID Numbers ^ICMJE

810241

Has Data Monitoring Committee

Not Provided

Responsible Party

Barbara Schmidt, MD, University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Barbara Schmidt, MD

University of Pennsylvania/Children's Hospital of Philadelphia

Information Provided By

University of Pennsylvania

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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