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Early ibuprofen administration to prevent patent ductus arteriosus in premature newborn infants
A Varvarigou1, C L Bardin, K Beharry
1Department of Neonatology, Lady Davis Institute-SMBD Jewish General Hospital, Montreal, Quebec, Canada.
Insights
Early ibuprofen administration in preterm infants significantly reduced patent ductus arteriosus (PDA) incidence. This treatment also improved respiratory outcomes and led to earlier hospital discharge without early adverse effects.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Pediatric Cardiology
Background:
- Patent ductus arteriosus (PDA) is a common complication in preterm neonates.
- Early intervention strategies are crucial for improving neonatal outcomes.
Purpose of the Study:
- To evaluate the efficacy of early postnatal intravenous ibuprofen in preventing PDA in preterm infants.
- To assess the safety and impact of ibuprofen on respiratory and other clinical outcomes.
Main Methods:
- A prospective sequential controlled trial involving 34 preterm infants.
- Infants received either three doses of ibuprofen, one dose of ibuprofen, or saline within 3 hours of birth.
- PDA was assessed by echocardiography and clinical evaluation at 3, 7, and 21 days of life.
Main Results:
- Three doses of ibuprofen significantly reduced PDA incidence compared to saline (0/12 vs 7/11, P < .02).
- Ibuprofen treatment was associated with improved respiratory parameters, including lower airway pressures and better oxygenation.
- Infants receiving three doses of ibuprofen experienced earlier full oral feedings, shorter hospitalization, and earlier discharge.
Conclusions:
- Early postnatal administration of three doses of ibuprofen effectively reduces PDA in preterm neonates.
- This treatment strategy is associated with improved respiratory outcomes and earlier hospital discharge without significant early adverse effects.
- Intravenous ibuprofen is a promising therapeutic option for preventing PDA in high-risk preterm infants.
Objective:
To test whether early postnatal (0 to 3 hours) intravenous administration of ibuprofen will prevent patent ductus arteriosus (PDA) in preterm neonates.
Design:
Prospective sequential controlled trial with three treatment arms.
Setting:
Level 3 perinatal-neonatal intensive care nursery.
Patients:
Thirty-four premature newborn infants born from February to August 1993 with a mean birth weight of 913 g (range, 565 to 1460 g) and gestational age of 26.9 weeks (range, 22.4 to 31.0).
Intervention:
Infants were consecutively assigned within 3 hours of age to treatment with either one dose of ibuprofen lysine (10 mg/kg intravenously) followed by 5 mg/kg per dose intravenously at 24 and 48 hours of age (n = 12), one dose of ibuprofen lysine (10 mg/kg intravenously; n = 11), or saline (n = 11).
Outcome Variables:
Primary outcome variable was the presence of ductus arteriosus by echocardiography and clinical assessments at 3, 7, and 21 days of life. Secondary outcome variables included presence of intraventricular hemorrhage, renal function, ventilatory and oxygen needs, hematologic changes, gastrointestinal function, time to full enteral feeding, duration of hospitalization, and age at discharge.
Results:
The three groups of patients were comparable in birth weight, gestational age, antenatal administration of betamethasone, and other perinatal characteristics. Ibuprofen treatment significantly reduced plasma levels of prostaglandins, and the levels remained low for 72 hours in newborns who received three doses of the drug. The incidence of PDA and other variables did not differ between patients who received a single dose of ibuprofen and those given saline. However, compared with the saline-treated newborns, babies who received three doses of ibuprofen had no PDA (0/12 vs 7/11 for saline; P < .02), had lower daily mean airway pressures (mean +/- SD, 5.2 +/- 1.1 cm H2O vs 8.3 +/- 2.8 cm H2O for saline; P < .02) and better oxygenation index (2.6 +/- 0.6 vs 4.7 +/- 1.8 for saline; P < .02) at the end of the first week of life, and required fewer days of ventilation (25 +/- 14 days vs 44 +/- 26 days for saline; P < .03). Babies given three doses of ibuprofen tended to tolerate full oral feedings earlier (35 +/- 19 days vs 56 +/- 34 days for saline; P = .09), had shorter duration of hospitalization (71.2 +/- 22.6 days vs 127.3 +/- 74.7 days for saline; P < .05), and were discharged to home at an earlier postconceptional age (37.8 +/- 2.0 weeks vs 44.8 +/- 9.8 weeks for saline; P < .05). ibuprofen treatment in this phase I trial was not associated with any apparent early neurological, intestinal, renal, hepatic, or hematologic complications.
Conclusions:
Administration of three doses of ibuprofen within 3 hours after birth in preterm neonates reduced the incidence of PDA without causing notable early adverse drug reactions in this phase I trial. Early closure of the ductus arteriosus was also associated with better respiratory outcome and earlier discharge from the hospital.