Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry.
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Palomino Laura, Velasco Rodríguez-Belvís Marta, Casanova María José, Leo-Carnerero Eduardo, Calviño-Suárez Cristina, Rivero Montserrat, Calvo Marta, Arroyo María Teresa, Fernández-Clotet Agnes, Pérez-Martínez Isabel, Masedo González Ángeles, Hernández Vicent, Ruiz-Cerulla Alexandra, López Serrano Pilar, Vega Pablo, Rodríguez-Lago Iago, Lidón Raquel Vicente, De Jorge Miguel Ángel, Guerra Iván, García Lara Arias, Molina Arriero Gema, Hervías Cruz Daniel, Busquets David, Gutiérrez Casbas Ana, Van Domselaar Manuel, Valldosera Gomis Gemma, Vázquez Morón Juan María, Piqueras Cano Marta, Lucendo Alfredo J, Martín Arranz María Dolores, Ramírez de la Piscina Patricia, Martínez Tirado María Del Pilar, Robles Alonso Virginia, Marín Pedrosa Sandra, Camargo Camero Raquel, Armesto Gonzalez Edisa, Tardillo Marín Carlos, Bernardos Martín Esther, Rodríguez Grau María Carmen, Huguet José M, Márquez-Mosquera Lucía, Sendra Rumbeu Pau, Bujanda Luis, Castaño-Milla Carlos, Sáinz Arnau Empar, Hernández Luis, Ramos Laura, Boscá-Watts M M, Manceñido Marcos Noemí, Sans Miquel, Morales Victor Jair, Acosta Diana, Garre Ana, Muñoz Codoceo Rosana, García-Salido Alberto, Gisbert Javier P, Chaparro María, DUMBO study group of GETECCU
Аннотация
METHODS: The study included patients and infants from DUMBO, an ongoing prospective, observational registry of GETECCU enrolling pregnant women (aged ≥18 years) with IBD from 60 centers across Spain. Mothers were followed up at each trimester during pregnancy and after delivery. Psychomotor development of infants was assessed using the Spanish version of the Ages and Stages Questionnaire 3rd edition (ASQ-3) during the first year of life. An ASQ-3 score below the normal limit in any domain was considered abnormal.
RESULTS: In total, 352 children born to 343 women were assessed; 134 infants (38.1%) were exposed to biologics during pregnancy and 80 (22.7%) during lactation, including 5 who were exclusively breastfed. At 12 months, the proportions of infants with normal ASQ-3 total scores (86% vs 74%; P = .031) and normal gross motor domain scores (91% vs 81%; P = .033) were significantly higher in the biologics-exposed vs nonexposed subgroups. Multivariate analysis revealed that preterm birth (odds ratio, 0.3; 95% confidence interval, 0.1-0.6) and maternal ulcerative colitis (odds ratio, 0.5; 95% confidence interval, 0.3-0.9) were associated with an increased risk of abnormal ASQ-3. Other variables, including exposure to biologics in utero, had no impact on ASQ-3 scores at month 12.
CONCLUSIONS: Exposure to biologics for IBD in utero or during breastfeeding has no negative impact on psychomotor development in infants.
GOV, NUMBER: NCT03894228.