Pharmacy and Therapeutics: Medication Safety Research
Pediatric Therapeutics and Pharmacology
Jean-Michel HASCOET, MD (he/him/his)
Head of Neonatology Department
University of Lorraine
NANCY, Lorraine, France
Term neonates born in a level III Maternity Hospital between 01/01/2017 and 12/31/2020 were included in a retrospective study. Newborns exposed to ACS < 34 WG were randomly selected from eligible births, then matched on sex and year of birth to 2 non-exposed controls. Data were collected in infants’ file regarding the history of pregnancy, birth biometric parameters (weight (BW), height (BH), head circumference (HC)), and neonatal adaptation including infection, hypoglycemia, hypocalcemia and eating difficulties. Multivariate analysis assessed the impact of ACS on neonatal outcome.
Results:
136 full-term newborns exposed to ACS for a risk of preterm delivery were compared to 272 non-exposed controls. Mean±SD [Median centiles] HC was 33.7±1.4 vs 34.3±1.6 cm, p=0.001 [34 vs. 46] in exposed vs non-exposed controls respectively; BW=3.1±0.4 vs. 3.3±0.4 Kg [38 vs. 46] p< 0.001; BH=47.9±2.1 vs. 49.1±2.0 cm [28 vs. 34] p< 0.001.
The rate of hypocalcemia (4.4 vs. 0.7% p=0.019) and eating difficulties (5.1 vs. 1.5% p=0.047) was significantly higher in case of ACS exposure. There was no significant difference in bivariate analysis for hypoglycemia (8.1 vs. 3.7% p = 0.057), or infection rate (0.0 vs. 1.8% p=0.174). Multivariate analysis for HC at birth showed a significant association with ACS (β=-0.5, p=0.009), passive maternal smoking (β=0.8, p=0.004), eating difficulties (β=-1.7, p=0.005), hypoglycemia (β=0.8, p=0.012) and hypocalcemia (β=1.1, p=0.042).
Conclusion(s):
Term neonates exposed to ACS for a threat of preterm delivery have a smaller HC, BW & BH at birth than those not exposed and a higher risk of neonatal metabolic complications. These data do not question the indication of ACS in case of a risk of preterm delivery but raise caution on excessive ACS prescription in low-risk pregnancies. Follow-up of ACS exposed term born neonates would allow excluding long term sustained side effects of this therapy.