PEDIATRICS Vol. 93 No. 5 May 1994, pp. 730-736
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Prenatal Dexamethasone Treatment in Conjunction with Rescue Therapy of Human Surfactant: A Randomized Placebo-Controlled Multicenter Study

M. Anneli Kari MD1, Marianne Eronen MD1, Martti Virtanen MD1, Mikko Hallman MD2, Kari Teramo MD3, Maila Koivisto MD4, and R. S. Ikonen MD5

1 Children's Hospital, University of Helsinki
2 Department of Pediatrics, University of California, Irvine, California
3 Departments I and II of Obstetrics and Gynecology, University of Helsinki
4 Department of Pediatrics, University of Oulu
5 Department of Pediatrics, University of Tampere, Finland

Objectives. A placebo-controlled, randomized, double-blind study was performed to determine whether prenatal dexamethasone (DEX) treatment improves the outcome of the preterm infant when exogenous surfactant is available.

Methods. 157 pregnant women at five hospitals with threatened preterm delivery and with lengths of gestation <32 weeks received either DEX (dose 6 mg four times at 12-hour intervals) or placebo (PL). Prenatal treatment was not repeated. Preterm infants received rescue therapy of human surfactant (maximum four doses) if they required ventilatory support and at least 40% oxygen for the treatment of respiratory distress syndrome (RDS).

Results. Enrolled pregnant women delivered 188 live-born neonates, of whom 79 (DEX 41 and PL 38 neonates) were born 1 to 14 days after the prenatal treatment. Neonates born within 1 to 14 days after the initial DEX treatment had a lower incidence of RDS (DEX, 44%; PL, 79%; P < .01), lower requirements of surfactant (DEX, 22%; PL, 53%; P < .01), shorter duration of ventilatory support (DEX, 2.0 days; PL, 5.3 days; P < .05) and oxygen therapy (DEX, 2.0 days; PL, 7.0 days; P < .01), and a higher neonatal survival without ventilatory support (P < .05) than PL-treated neonates. DEX-treated neonates had higher mean blood pressure than PL-treated neonates during the first 3 days after birth. Among all neonates treated with DEX, there was a lower incidence of intraventricular hemorrhage or periventricular leucomalacia (DEX, 13%; PL, 33%; P < .01). Reduction in the incidence of intraventricular hemorrhage or periventricular leucomalacia in DEX-treated neonates was particularly associated with exogenous human surfactant therapy (DEX + surfactant 10%; PL + surfactant 48%; P < .01).

Conclusions. Prenatal DEX treatment combined with exogenous human surfactant therapy in preterm infants decreases pulmonary morbidity and cerebral complications, and increases survival without severe morbidity.

Submitted on July 16, 1993
Accepted on October 28, 1993




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