Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry
Year: 2025
Type: article
Study design: Observational Study
Abstract: BACKGROUND & AIMS: The 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. 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.
Authors: Laura Palomino, Marta Velasco Rodríguez-Belvís, María José Casanova, Eduardo Leo-Carnerero, Cristina Calviño-Suárez, Montserrat Rivero, Marta Calvo, María Teresa Arroyo, Agnes Fernández-Clotet, Isabel Pérez-Martínez, Ángeles Masedo González, Vicent Hernández, Alexandra Ruiz-Cerulla, Pilar López Serrano, Pablo Vega, Iago Rodríguez-Lago, Raquel Vicente Lidón, Miguel Ángel De Jorge, Iván Guerra, Lara Arias García, Gema Molina Arriero, Daniel Hervías Cruz, David Busquets, Ana Gutiérrez Casbas, Manuel Van Domselaar, Gemma Valldosera Gomis, Juan María Vázquez Morón, Marta Piqueras Cano, Alfredo J. Lucendo, María Dolores Martín Arranz, Patricia Ramírez de la Piscina, María del Pilar Martínez Tirado, Virginia Robles Alonso, Sandra Marín Pedrosa, Raquel Camargo Camero, Edisa Armesto Gonzalez, Carlos Tardillo Marín, Esther Bernardos Martín, María Carmen Rodríguez Grau, José M. Huguet, Lucía Márquez-Mosquera, Pau Sendra Rumbeu, Luis Bujanda, Carlos Castaño-Milla, Empar Sáinz Arnau, Luis Hernández, Laura Ramos, M.M. Boscá-Watts, Noemí Manceñido Marcos, Miquel Sans, Victor Jair Morales, Diana Acosta, Ana Garre, Rosana Muñoz Codoceo, Alberto García-Salido, Javier P. Gisbert, María Chaparro, Elvira Cañedo Villarroya, Agustín de la Mano Hernández, Eva María Andrés Esteban, Sandra Hermida Vázquez, Pablo Parra Pineda, Almudena Durán Vegue, Andrea Núñez, María Dolores de La Cruz, María Rojas, Manuel Barreiro de Acosta, Laura Nieto, Coral Rivas, María Isabel Vera Mendoza, Virginia Matallana Royo, Belén Botella Mateu, Irene González Partida, Rocío de Lucas, Erika Alfambra, Elena Ricart Gómez, Sabino Riestra Menéndez, Ruth de Francisco García, Andrés Castaño García, Lorena Carballo Folgoso, Emilia Fernández González, Yago González Lama, Montserrat Figueira Álvarez, Romina Fernández-Poceiro, Ana Isabel Santamaria, Elena Sánchez-Pastor, Silvia Antón-Güell, José L. Pérez Calle, Cristina Regueiro Éxposito, Irene Moraleja Yudego, Mónica Belén Gonzales Balseca, Santiago García, Eva Serra Moros, María Sofia Gallego, Pilar Corsino, Pilar Varela Trastoy, Alejo Mancebo Mata, Ana Cruz González Fernández, Sara Barrero, Beatriz Sicilia Aladren, Ana Echarri Piudo, Virginia Ollero Pena, Leyanira Torrealba, Margarita Menacho, David Monfort Miquel, Raquel Mena Sánchez, Eduardo Martín Arranz, Cristina Suárez Ferrer, Joaquín Poza Cordón, María Sánchez Azofra, José Luis Rueda García, Laura García Ramírez, Cristina García-Rojas Pleite, Maria Ángeles Ogueta Fernández, Sonia Romero Izquierdo, Ruth Baltar Arias, Katerina Spicakova, Begoña Álvarez Arias, Andoni Pedraza Pérez, Beatriz Zúñiga de Mora-Figueroa, Salvadora Benito Palma, Claudia Herrera de Guise, Eva Iglesias Flores, José Manuel Benítez, Pilar Soto Escribano, Rosario Medina, Sandra González Rubio, Javier Sola Sánchez, María Capilla Igual, Lucía Ruiz Sánchez, Ana Monzó Gallego, Inmaculada Bort Pérez, Daniel Ginard Vicens, Edurne Poza San Miguel, José María Huguet, María Capilla Igual, Lucía Ruiz Sánchez, Ana Monzó Gallego, Inmaculada Bort Pérez, Gisela Torres Vicente, Carmen Orenga
Institutions: Hospital Infantil Universitario Niño Jesús, Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa, Hospital Universitario de La Princesa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Universidad Autónoma de Madrid, Hospital Universitario Virgen del Rocío, Complejo Hospitalario Universitario de Santiago, Marqués de Valdecilla University Hospital, Instituto de Investigación Marqués de Valdecilla, Hospital Universitario Puerta de Hierro Majadahonda, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragón, Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias, Hospital Universitario 12 De Octubre, Servicio Gallego de Salud, Estructura Organizativa de Xestión Integrada de Vigo, Universidade de Vigo, Bellvitge University Hospital, Hospital Universitario Fundación Alcorcón, Complejo Hospitalario de Ourense, Hospital de Galdakao, Hospital Universitario Miguel Servet, Hospital Universitario De Cabueñes, Hospital Universitario de Fuenlabrada, Hospital Universitario de Burgos, Complejo Hospitalario Universitario de Ferrol, Hospital General Universitario de Ciudad Real, Hospital Universitari de Girona Doctor Josep Trueta, Hospital General Universitario de Alicante Doctor Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Universidad Francisco de Vitoria, Hospital Universitario de Torrejón, Hospital Universitari Joan XXIII de Tarragona, Hospital Juan Ramón Jiménez, Consorci Sanitari de Terrassa, Hospital General de Tomelloso, Hospital Universitario La Paz, Complejo Hospitalario Universitario de Granada, Vall d'Hebron Hospital Universitari, Hospital Universitario Reina Sofía, Hospital Clínico Universitario Virgen de la Victoria, Hospital Universitario San Agustín, Hospital Universitario Nuestra Señora de Candelaria, Servicio de Salud de Castilla La Mancha, Hospital Universitario del Henares, Hospital General Universitario De Valencia, Hospital Del Mar, Municipal Institute for Medical Research, Hospital del Mar Research Institute, Hospital Universitario Son Espases, University of the Basque Country, Biogipuzkoa Health Research Institute, Hospital Universitario Rey Juan Carlos, Gerencia Regional de Salud de Castilla y León (Sacyl), Hospital Universitario de Canarias, Hospital Clínico Universitario de Valencia, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Hospital Quirón Teknon, Hospital General de Granollers
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,470
Funders: Euskal Herriko Unibertsitatea, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Investigación Marqués de Valdecilla, Instituto de Investigación Sanitaria del Principado de Asturias, Instituto de Salud Carlos III, Servicio Gallego de Salud, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Award: G5395758298
OpenAlex ID: W4411276402