Paracetamol Treatment of the Borderline Significant PDA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-01-31

Brief Summary

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The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate remains controversial. Currently it is generally accepted to treat only hemodynamically significant PDAs. The current investigation aims to study the effect of treatment on PDAs of borderline significance via a prospective, randomized controlled trial of paracetamol in this group.

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Detailed Description

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In the neonatal intensive care unit of the Shaare Zedek Medical Center, preterm babies \<30 wks. GA, are studied echocardiographically on day of life 3-4. Pending parental informed consent, those diagnosed with a PDA of borderline significance will be randomized to receive either paracetamol or placebo for three days, followed by a repeat echocardiogram. If the PDA remains of borderline significance, the treatment will be continued for an additional 4 days (1 week total). Paracetamol levels and liver functions will be assessed after the third day. Babies will be followed until discharge for subsequent PDA pathology; respiratory distress and chronic lung disease \[CLD\]; necrotizing enterocolitis \[NEC\]; retinopathy of prematurity \[ROP\].

The investigators' primary goal is to demonstrate a decrease in the composite outcome of death or severe morbidity chronic lung disease \[CLD\], as shown by decreased time on supplemental oxygen and assisted ventilation.

Secondary goals:

* To demonstrate a decrease in subsequently diagnosed hs PDA, including

* Decrease in the need for subsequent therapy for PDA closure
* Decrease in surgical PDA ligations
* To demonstrate a decrease in necrotizing enterocolitis (NEC) and/or ROP with treatment.
* To demonstrate no adverse effect on blood flow in anterior cerebral, superior mesenteric and renal arteries.

Conditions

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Patent Ductus Arteriosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

Treatment with placebo at a volume of 2.25 cc/kg/dose x 4/day to be given with feeds, or in place of feed when baby is receiving \<2 cc/kg/feed.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2.25 ml/kg/dose x 4/day of sterile water to be given for three days

Treatment Group

Treatment with paracetamol drops at 15 mg/kg/dose x 4/day. Drops will be diluted 1:15 in order to reduce osmolality. This will yield a dose of 2.25 ml/kg/dose, to be given with feeds, or in place of feed when baby is receiving \<2 cc/kg/feed.

Group Type ACTIVE_COMPARATOR

Paracetamol drops

Intervention Type DRUG

15 mg/kg/dose x 4/day diluted 1:15 yielding dose of 2.25 ml/kg/dose to be given for three days

Interventions

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Paracetamol drops

15 mg/kg/dose x 4/day diluted 1:15 yielding dose of 2.25 ml/kg/dose to be given for three days

Intervention Type DRUG

Placebo

2.25 ml/kg/dose x 4/day of sterile water to be given for three days

Intervention Type OTHER

Other Intervention Names

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Novimol

Eligibility Criteria

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Inclusion Criteria

* Preterm neonates \< 30 weeks' gestational age PDA of borderline significance

Exclusion Criteria

* Infants not deemed likely to survive more than one week Infants with congenital heart malformations Infants with pulmonary hypertension and right to left ductal shunting

Minimum Eligible Age

3 Days

Maximum Eligible Age

6 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No