Randomized controlled trial2023Open access

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 citations

Review labels

Controlled feeding

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Clinical events such as disease or death
Intake measured by
Food provided by researchers

Who paid for it

Funding
Independent funding
Government
Japan Society for the Promotion of Science
Grants
Japan Society for the Promotion of Science (21K03123)

Based on 1 listed funder(s).

Publication

Published
2023-07-10 · JAMA Netw Open · vol. 6 · issue 7 · p. e2322318
Publisher
American Medical Association
Cited
12 citations · more than 84% of similar papers · 1.7× the field average
References
64 works
Access
Open access (journal) · CC-BY
Research areas
Food Allergy and Anaphylaxis Research · Infant Nutrition and Health · Breastfeeding Practices and Influences
Keywords
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 authors

From JP

  • Ken‐ichi NagakuraJikei University School of Medicine; National Sagamihara Hospital
  • Sakura SatoNational Sagamihara Hospital
  • Wakako ShinaharaTokushima University
  • Hiroshi KidoTokushima University
  • Hidetoshi FujitaSeiwa Hospital
  • Takanori YanaiNational Hospital Organization

Abstract

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.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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