Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Clin Pediatr. Dec 9, 2026; 15(4): 124805
Published online Dec 9, 2026. doi: 10.5409/wjcp.124805
Published online Dec 9, 2026. doi: 10.5409/wjcp.124805
Early lactase enzyme supplementation: Efficacy to promote growth and feeding tolerance in preterm infants: A randomized controlled trial
Walaa E M A Morsi, Ayman E Eskander, Zahraa Ezz ElDin, Amira Elrefaee, Department of Pedi
Mohamed G Mostafa, Pediatric and Neonatology Consultant, Ministry of Health and Population, Cairo 11516, Al Qāhirah, Egypt
Fatma A Abdel Maksoud, Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo 11956, Al Qāhirah, Egypt
Author contributions: Morsi WEMA and Elrefaee A designed the research study; Morsi WEMA, Eskander AE, Mostafa MG, and Ezz ElDin Z performed the research and collected the clinical data; Abdel Maksoud FA performed the laboratory investigations and contributed to data interpretation; Morsi WEMA and Abdel Maksoud FA analyzed the data; Morsi WEMA and Elrefaee A drafted the manuscript; Eskander AE, Mostafa MG, Ezz ElDin Z, and Elrefaee A critically revised the manuscript for important intellectual content; Elrefaee A supervised the study; and all authors read and approved the final version of the manuscript.
AI contribution statement: No artificial intelligence tools were used in the preparation of this manuscript.
Institutional review board statement: The study protocol was approved by the Research Ethics Committee of Cairo University Faculty of Medicine, Cairo, Egypt (approval No. MD-33-2022).
Clinical trial registration statement: This trial was retrospectively registered at ClinicalTrials.gov (Identifier: NCT07494123).
Informed consent statement: Written informed consent was obtained from the legal guardians of all enrolled preterm infants before study participation.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: The dataset and statistical code are available from the corresponding author upon reasonable request.
Corresponding author: Amira Elrefaee, MD, Lecturer, Department of Pediatrics, Faculty of Medicine, Cairo University, Al-Manial, Cairo 11956, Al Qāhirah, Egypt.
Received: June 24, 2026
Revised: August 6, 2026
Accepted: August 26, 2026
Published online: December 9, 2026
Processing time: 87 Days and 4.6 Hours
Revised: August 6, 2026
Accepted: August 26, 2026
Published online: December 9, 2026
Processing time: 87 Days and 4.6 Hours
Core Tip
Core Tip: This randomized, double-blind controlled trial evaluated lactase enzyme supplementation in preterm infants born before 34 weeks of gestation. Lactase supplementation improved feeding tolerance by reducing gastric residuals, abdominal distension, emesis, and diarrhea. It was also associated with improved stool reducing-substance results, higher fecal pH, and greater daily weight gain. In addition, fewer infants developed necrotizing enterocolitis in the lactase group. These findings suggest that lactase supplementation may be a safe and useful adjunct to enteral feeding in preterm infants.