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Completed

NCT Number: NCT01031316

Patent Ductus Arteriosus (PDA) Screening Trial

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.

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Key information

Conditions

Ductus Arteriosus, Patent Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nondisclosure of screening echocardiogram results

Other

Subjects will be randomized to nondisclosure of screening echocardiogram results.

Disclosure of screening echocardiogram results

Other

Subjects will be randomized to disclosure of screening echocardiogram results.

Primary outcomes

  1. Number of days to regain birth weight.

    Time frame: 1-4 weeks

Secondary outcomes

  1. Treatment for a PDA with indomethacin or surgical ligation.

    Time frame: 3-6 months

  2. Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.

    Time frame: 3-6 months

  3. Number of days to 120ml/kg/day of enteral feedings (full feeds).

    Time frame: 3-6 months

  4. Ventilator days, number of days of positive airway pressure, and number of days in oxygen.

    Time frame: 3-6 months

  5. Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.

    Time frame: 3-6 months

  6. Confirmed or suspected sepsis.

    Time frame: 3-6 months

  7. Worst stage of retinopathy of prematurity.

    Time frame: 3-6 months

  8. Day of death or discharge.

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 14, 2009
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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