Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial
| Registry | NCT03641209, acronym Paras |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 40 (Actual) |
| Sponsor | Outi Aikio (Other) |
| Conditions | Prematurity; Extreme, Low Birthweight, Extremely (999 Grams or Less) |
| Interventions | Paracetamol 10mg/mL infusion solution, Placebo (Drug, other) |
| Dates | start 2018-09-03, primary completion 2023-11-03, completion 2024-03-01, first posted 2018-08-21, last updated 2024-03-15 |
| Locations | 1 site in Finland |
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All trials for Prematurity; Extreme All trials for Low Birthweight, Extremely (999 Grams or Less) All trials of Paracetamol 10mg/mL infusion solution All trials of Placebo
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
The purpose of this randomized, placebo-controlled, double-blind, phase 2, one center clinical trial is to study the efficacy and safety of early (< 96 h) intravenous paracetamol in prophylactic closure of ductus arteriosus in extremely premature (gestational age <28+0 wk, ELGA) or low birth weight (<1000 g, ELBW) infants. The infants born extremely preterm or low birth weight are a focus of the study, since a small phase 2 study on paracetamol failed to demonstrate contraction of ductus arteriosus.
In the investigator's previous cohort of ELGA/ELBW infants, the numbers of patients who needed any therapies for patent ductus arteriosus (PDA) were 29 (23%) in the paracetamol exposed group, and 90 (54%) in the control group. As demonstrated in a phase 2 study, the early paracetamol treatment induced the closure of ductus arteriosus: the mean (SD) ductal closure age was 177 (338) h in the whole paracetamol group. However, in the subgroup of ELGA infants born before 28 gestation weeks (n=14), the mean (SD) ductal closure ages in the paracetamol and placebo groups were 491 (504) h and 858 (719) h, respectively.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Paracetamol | Experimental | Drug: Paracetamol 10mg/mL infusion solution | Paracetamol 10 mg/mL infusion solution, intravenous loading dose 20 mg/kg, followed by maintenance dose 7.5 mg/kg every 6 h up to 9 days |
| Placebo | Placebo comparator | Other: Placebo | 0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug |
Sex: All, ages: any to 96 Hours
Inclusion Criteria: * Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g Exclusion Criteria: * Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Pediatrics, Oulu University Hospital | Oulu | Finland |