Phase 2 N=202 Randomized Single-blind Treatment

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

Patent Ductus Arteriosus · Surgery · Necrotizing Enterocolitis · Intestinal Perforation

Bottom Line

View on ClinicalTrials.gov: NCT01958320 ↗

Enrolled (actual)

202

Serious AEs

17.8%

Results posted

Nov 2018

Primary outcome: Primary: Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits) — 33; 38 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: pharmacologic treatment of the PDA (Other); no pharmacologic treatment of the PDA (Other); NSAID (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits)	33; 38	—
SECONDARY Duration of Gavage Feeding Assistance	76; 80	—
SECONDARY Incidence of Necrotizing Enterocolitis or Spontaneous Perforation	17; 19	—
SECONDARY the Average Daily Weight Gain	22.5; 22.8	—
SECONDARY Incidence of Bronchopulmonary Dysplasia or Death	60; 56	—
SECONDARY Incidence of Death	20; 10	—
SECONDARY the Incidence of Persistent Moderate-to-large PDA Shunt 10 Days After Enrollment	43; 78	—
SECONDARY the Incidence of Rescue Treatment Eligibility Criteria Met	32; 61	—
SECONDARY Number of Infants Receiving ≥ 14 Days of Diuretic Treatment	36; 45	—

Summary

The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth. The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".

Eligibility Criteria

Inclusion Criteria

This will be a prospective randomized, multi-center, controlled trial that will enroll infants delivered between 23 & 0/7 - 27 & 6/7 weeks gestation:

infants must be between 5-14 days old (if delivered between 23 and 0/7 - 25 and 6/7 weeks) or 7-14 days old (if delivered between 26 & 0/7 - 27 & 6/7 weeks) and
have a "moderate size PDA" (defined as a PDA on echocardiogram that has at least one of the following criteria: internal ductus diameter ≥1.5 mm/kg (or PDA:LPA ratio ≥0.5), ductus flow velocity ≤2.5 m/s or mean pressure gradient across the ductus 0.2 (or >0.42) m/sec, respectively, and/or reversed diastolic flow in the descending aorta)(13, 68, 69) and
are receiving respiratory support consisting of either mechanical ventilation, nasal CPAP, SiPAP, or nasal cannula flow ≥2 L/min.

Exclusion Criteria

prior treatment with indomethacin, ibuprofen, or acetaminophen, contraindications for the use of indomethacin, ibuprofen, or acetaminophen (these include: hydrocortisone administration within 24 hrs, urine output 1.6 mg/dl, platelet count 8 x weight (in kg)), chromosomal anomalies, congenital or acquired gastrointestinal anomalies, prior episode of necrotizing enterocolitis or intestinal perforation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01958320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.