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Ensayo controlado aleatorizado2023Alimentación controladaAcceso abierto

Effect of Maternal Egg Intake During the Early Neonatal Period and Risk of Infant Egg Allergy at 12 Months Among Breastfeeding Mothers: A Randomized Clinical Trial

Nagakura KI, Sato S, Shinahara W, Kido H, Fujita H, Yanai T, Akiyama N, Futamura M, Koga H, Fujiwara M, Kaneko H, Taniguchi H, Makita E, Takahashi K, Yanagida N, Ebisawa M, Urashima M

JAMA network open · 8 citas

Etiquetas de revisión

Alimentación controlada

Datos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte
Consumo medido con
Comida provista por los investigadores

Quién lo pagó

Financiación
Financiación independiente
Gobierno
Japan Society for the Promotion of Science
Subvenciones
Japan Society for the Promotion of Science (21K03123)

Según 1 financiador declarado.

Publicación

Publicado
2023-07-10 · JAMA Netw Open · vol. 6 · número 7 · pág. e2322318
Editorial
American Medical Association
Citado
12 citas · más que el 84% de estudios similares · 1.7× el promedio de su campo
Referencias
64 trabajos
Acceso
Acceso abierto (revista) · CC-BY
Áreas de investigación
Food Allergy and Anaphylaxis Research · Infant Nutrition and Health · Breastfeeding Practices and Influences
Palabras clave
Medicine, Breastfeeding, Egg allergy, Breast feeding, Randomized controlled trial, Pediatrics, Food allergy, Allergy, Breast milk, Ingestion, Egg white, Obstetrics, Internal medicine, Immunology, Biology
MeSH
milk, human, humans, egg hypersensitivity, ovalbumin, ovomucin, single-blind method, mothers, breast feeding, infant, infant, newborn, female, male

17 autores

  • Ken‐ichi Nagakura🇯🇵Jikei University School of Medicine; National Sagamihara Hospital
  • Sakura Sato🇯🇵National Sagamihara Hospital
  • Wakako Shinahara🇯🇵Tokushima University
  • Hiroshi Kido🇯🇵Tokushima University
  • Hidetoshi Fujita🇯🇵Seiwa Hospital
  • Takanori Yanai🇯🇵National Hospital Organization
  • Nao Akiyama🇯🇵National Hospital Organization; National Hospital Organization Saitama Hospital
  • Masaki Futamura🇯🇵National Hospital Organization; Nagoya Medical Center
  • Hiroshi Koga🇯🇵Beppu Medical Center; National Hospital Organization
  • Michimasa Fujiwara🇯🇵Fukuyama Cardiovascular Hospital; National Hospital Organization
  • Hideo Kaneko🇯🇵Nagara Medical Center; Gifu Prefectural General Medical Center; National Hospital Organization
  • Hiroaki Taniguchi🇯🇵Konan Medical Center
  • Eishi Makita🇯🇵Jichi Medical University; Jichi Medical University Saitama Medical Center
  • Kyohei Takahashi🇯🇵National Sagamihara Hospital
  • Noriyuki Yanagida🇯🇵National Sagamihara Hospital
  • Motohiro Ebisawa🇯🇵National Sagamihara Hospital
  • Mitsuyoshi Urashima🇯🇵 · autor de correspondenciaJikei University School of Medicine

Resumen

El texto original del estudio, en el idioma en que se publicó.

Importance

Egg introduction in infants at age 4 to 6 months is associated with a lower risk of immunoglobulin E-mediated egg allergy (EA). However, whether their risk of EA at age 12 months is affected by maternal intake of eggs at birth is unknown.

Objective

To determine the effect of maternal egg intake during the early neonatal period (0-5 days) on the development of EA in breastfed infants at age 12 months.

Design, setting, and participants

This multicenter, single-blind (outcome data evaluators), randomized clinical trial was conducted from December 18, 2017, to May 31, 2021, at 10 medical facilities in Japan. Newborns with at least 1 of 2 parents having an allergic disease were included. Neonates whose mothers had EA or were unable to consume breast milk after the age of 2 days were excluded. Data were analyzed on an intention-to-treat basis.

Interventions

Newborns were randomized (1:1) to a maternal egg consumption (MEC) group, wherein the mothers consumed 1 whole egg per day during the first 5 days of the neonate's life, and a maternal egg elimination (MEE) group, wherein the mothers eliminated eggs from their diet during the same period.

Main outcomes and measures

The primary outcome was EA at age 12 months. Egg allergy was defined as sensitization to egg white or ovomucoid plus a positive test result in an oral food challenge or an episode of obvious immediate symptoms after egg ingestion.

Results

Of the 380 newborns included (198 [52.1%] female), 367 (MEC: n = 183; MEE: n = 184) were followed up for 12 months. On days 3 and 4 after delivery, the proportions of neonates with ovalbumin and ovomucoid detection in breast milk were higher in the MEC group than in the MEE group (ovalbumin: 10.7% vs 2.0%; risk ratio [RR], 5.23; 95% CI, 1.56-17.56; ovomucoid: 11.3% vs 2.0%; RR, 5.55; 95% CI, 1.66-18.55). At age 12 months, the MEC and MEE groups did not differ significantly in EA (9.3% vs 7.6%; RR, 1.22; 95% CI, 0.62-2.40) or sensitization to egg white (62.8% vs 58.7%; RR, 1.07; 95% CI, 0.91-1.26). No adverse effects were reported.

Conclusions and relevance

In this randomized clinical trial, EA development and sensitization to eggs were unaffected by MEC during the early neonatal period.

Trial registration

UMIN Clinical Trials Registry: UMIN000027593.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).

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