Patent Ductus Arteriosus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGParacetamol 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
OTHERPlacebo
2.25 ml/kg/dose x 4/day of sterile water to be given for three days
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 6 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of death or severe morbidity chronic lung disease [CLD] | Day of life 3 until 40 weeks post-conception | Chronic lung disease will be assessed by time on supplemental oxygen and assisted ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subsequently diagnosed hs PDA | Completion of study intervention until 40 weeks post-conception | Will be assessed by subsequent need for medical or surgical intervention for closure of PDA |
| Subsequent incidence of necrotizing enterocolitis (NEC) and/or retinopathy of prematurity (ROP) | Completion of study intervention until 40 weeks post-conception | Study infants will be followed clinically and any occurrence of NEC or ROP will be recorded with its level of significance (Bell staging for NEC and Stage of ROP) |
Countries
Israel
Outcome results
None listed