Two-year follow-up of a randomized trial with repeated antenatal betamethasone

Outi M Peltoniemi ^1*, M Anneli Kari ², Aulikki Lano ², Anneli Yliherva PhD¹, Riina Puosi ², Liisa Lehtonen ³ and Mikko Hallman ¹

¹ University of Oulu, Finland
² Helsinki University Central Hospital, Finland
³ University of Turku, Finland

^* To whom correspondence should be addressed. E-mail: outi.peltoniemi{at}mail.suomi.net.

Accepted 26 May 2009

Abstract

Background: Weekly repeated antenatal corticosteroid treatment improves respiratory outcome but decreases fetal growth and may impair neurodevelopmental outcome. We have previously reported that a single repeat betamethasone (BM) dose neither decreased foetal growth nor improved the outcome of preterm infants during the first hospitalization.

Objective: To study prospectively whether a single repeat dose of BM influences neurodevelopment and growth within 2 years.

Design: Women with imminent delivery before 34.0 gestational weeks were eligible if they remained undelivered for more than 7 days after a single course of antenatal BM. After stratification, a single repeat dose of BM (12 mg) or placebo was given. The children underwent neurological and psychometric examinations and a speech evaluation at a corrected age of 2 years.

Setting: Prospective, blinded evaluation following the randomized multi-centre trial.

Patients: 259 (82 %) surviving infants completed the 2-year follow-up, 120 in the BM group and 139 in the placebo group.

Results: The rate of survival without severe neurodevelopmental impairment was similar in both groups (BM 98%, placebo 99 %). The risk of cerebral palsy (BM 2 %, placebo 1 %), growth or rehospitalization rates (BM 60 %, placebo 50 %) did not differ between the groups, either.

Conclusions: A single repeat dose of antenatal BM tended not to influence physical growth or neurodevelopment at 2 years of age.