Psychomotor development in infants following maternal exposure to biologics: Results from the DUMBO registry.

June 23, 2025

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Psychomotor development in infants following maternal exposure to biologics: Results from the DUMBO registry.

Publicated to:Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. (): S1542-3565(25)00488-4 - 2025-06-01 (), DOI: 10.1016/j.cgh.2025.05.012

Authors: Palomino L; Rodríguez-Belvís MV; Casanova MJ; Leo-Carnerero E; Suarez CC; Rivero M; Calvo M; Arroyo MT; Fernández-Clotet A; Pérez-Martínez I; González ÁM; Hernández V; Ruiz-Cerulla A; Serrano PL; Vega P; Rodríguez-Lago I; Lidón RV; De Jorge MÁ; Guerra I; García LA; Arriero GM; Cruz DH; Busquets D; Casbas AG; Van Domselaar M; Gomis GV; Vázquez Morón JM; Cano MP; Lucendo AJ; Martín Arranz MD; Ramírez de la Piscina P; Tirado MDPM; Alonso VR; Pedrosa SM; Camero RC; Gonzalez EA; Marín CT; Martín EB; Rodríguez Grau MC; Huguet JM; Márquez-Mosquera L; Rumbeu PS; Bujanda L; Castaño-Milla C; Arnau ES; Hernández L; Ramos L; Boscá-Watts MM; Marcos NM; Sans M

Affiliations

Bioodonostia Health Research Institute - Donostia University Hospital, Universidad del País Vasco (UPV/EHU), CIBEREHD, San Sebastián. - Author

Complejo Hospitalario Universitario de Ferrol, A Coruña. - Author

Complexo Hospitalario Universitario de Ourense, Ourense. - Author

Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela. - Author

Consorci Sanitari de Terrassa (CST), Barcelona. - Author

Hospital Clinic de Barcelona, CIBEREHD, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona. - Author

Hospital Clínico Universitario de Valencia, Valencia. - Author

Hospital Clínico Universitario Lozano Blesa, IIS Aragón and CIBEREHD, Zaragoza. - Author

Hospital Clínico Universitario San Cecilio, Granada. - Author

Hospital del Mar, Barcelona, IMIM (Hospital del Mar Medical Research Institute), Barcelona. - Author

Hospital General de Tomelloso, Tomelloso, Instituto de Investigación Sanitaria La Princesa, Instituto de Investigación Sanitaria de Castilla-La Mancha (IDISCAM) and CIBEREHD. - Author

Hospital General Universitario de Ciudad Real, Cuidad Real. - Author

Hospital General Universitario de Valencia, Valencia. - Author

Hospital General Universitario Dr. Balmis Alicante, ISABIAL, CIBERehd, Alicante. - Author

Hospital Infantil Universitario Niño Jesús and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid. - Author

Hospital Infantil Universitario Niño Jesús and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid. Electronic address: laura_palomino_perez@hotmail.es. - Author

Hospital Mancha Centro, Alcázar de San Juan. - Author

Hospital Sant Joan de Déu, Manresa and Hospital Universitario de La Princesa and CIBEREHD, Madrid. - Author

Hospital Santos Reyes Aranda de Duero SACyL, Aranda de Duero. - Author

Hospital Trueta de Girona, Girona. - Author

Hospital Universitario 12 de Octubre, Madrid. - Author

Hospital Universitario Central de Asturias, Oviedo Diet, Microbiota and Health Group, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo. - Author

Hospital Universitario de Álava, Vitoria-Gasteiz. - Author

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona. - Author

Hospital Universitario de Burgos, Burgos. - Author

Hospital Universitario de Cabueñes, Gijón; A Coruña. - Author

Hospital Universitario de Canarias, La Laguna Santa Cruz de Tenerife. - Author

Hospital Universitario de Fuenlabrada, Fuenlabrada. - Author

Hospital Universitario de Galdakao, Biobizkaia Health Research Institute, Barakaldo. - Author

Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid. - Author

Hospital Universitario de Torrejón and Universidad Francisco de Vitoria, Madrid. - Author

Hospital Universitario del Henares, Coslada, Madrid. - Author

Hospital Universitario Fundación Alcorcón, Madrid. - Author

Hospital Universitario Infanta Sofía San Sebastián de los Reyes, Madrid. - Author

Hospital Universitario Joan XXIII, Tarragona. - Author

Hospital Universitario Juan Ramón Jiménez, Huelva. - Author

Hospital Universitario La Paz, Madrid. - Author

Hospital Universitario Marqués de Valdecilla e IDIVAL, Santander. - Author

Hospital Universitario Miguel Servet de Zaragoza, Zaragoza. - Author

Hospital Universitario Nuestra Señora de Candelaria, Tenerife. - Author

Hospital Universitario Puerta de Hierro, Majadahonda. - Author

Hospital Universitario Reina Sofía, Córdoba. - Author

Hospital Universitario Rey Juan Carlos, Móstoles, Madrid. - Author

Hospital Universitario San Agustín, Avilés. - Author

Hospital Universitario Son Espases, Palma de Mallorca. - Author

Hospital Universitario Virgen de La Victoria, Málaga. - Author

Hospital Universitario Virgen del Rocío, Seville. - Author

Hospital Vall d´Hebrón, Barcelona. - Author

ISADMU Centro Médico Teknon Barcelona. - Author

Xerencia Xestión Integrada de Vigo, SERGAS Grupo de Investigación de Patología Digestiva, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur), SERGAS UVIGO, Vigo. - Author

Abstract

Background and aimsThe impact of biologic treatment for inflammatory bowel disease (IBD) during pregnancy and lactation on infant psychomotor development is barely studied. We investigated the effect of exposure to biologics in utero or during breastfeeding on the psychomotor development of offspring during their first year 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.ResultsIn 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 five who were exclusively breastfed. At 12 months, the proportions of infants with normal ASQ-3™ total scores (86% vs 74%; p=0.031) and normal gross motor domain scores (91% vs 81%; p=0.033) were significantly higher in the biologics-exposed versus non-exposed subgroups. Multivariate analysis revealed that preterm birth (OR 0.3; 95% CI 0.1-0.6) and maternal ulcerative colitis (OR 0.5; 95% CI 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.ConclusionsExposure to biologics for IBD in utero or during breastfeeding has no negative impact on psychomotor development in infants.

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Psychomotor development in infants following maternal exposure to biologics: Results from the DUMBO registry.

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