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Randomized Controlled Trial
. 2024 Nov 20;184(1):30.
doi: 10.1007/s00431-024-05861-4.

Influence of bovine lactoferrin on feeding intolerance and intestinal permeability in preterm infants: a randomized controlled trial

Nermeen Ellakkany  1   2 , Hesham Abdel-Hady  3 , Ahmed Mahfouz Eita  3 , Youssef M Mosaad  3 , Ahmed Megahed  3
Affiliations
Randomized Controlled Trial

Influence of bovine lactoferrin on feeding intolerance and intestinal permeability in preterm infants: a randomized controlled trial

Nermeen Ellakkany et al. Eur J Pediatr. .

Abstract

Objects: Preterm infants are at an increased risk of developing feeding intolerance (FI) due to the functional immaturity of their gastrointestinal tract. Recent studies and meta-analyses have shown a significant role of bovine lactoferrin (LF) in the management of feeding intolerance and sepsis. This study aimed to assess the effects of oral bovine LF supplementation on FI in preterm infants (26-34 weeks gestational age) and its effect on intestinal permeability measured by serum zonulin concentrations.

Methods: A randomized controlled double-blind interventional pilot study was conducted in the Neonatal Intensive Care Unit (NICU) of Mansoura University. Sixty preterm neonates with FI were included in the study and were randomly assigned into two groups: lactoferrin group (100 mg/day bovine LF for 4 weeks or until discharge) and control group.

Results: The time needed to achieve full enteral feeding of sixty preterm infants (26-34 weeks gestational age) (9 vs. 15 days, P = 0.001) was significantly shorter and serum zonulin concentrations at end of the trial or discharge (3.38 vs. 5.49 ng/ml, P = 0.04) were significantly lower in the lactoferrin group compared with the control group.

Conclusion: Oral bovine lactoferrin given to preterm infants (26-34 weeks gestational age) is associated with improvement of feeding intolerance and decreased intestinal permeability.

Trial registration: This study was registered at clinical trials.gov with ID (NCT04738058) at 2 March 2021.

Keywords: Bovine lactoferrin; Feeding intolerance; Preterm infants.

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Conflict of interest statement

Declarations: The study was carried out in accordance with the Declaration of Helsinki [32], and the study protocol was approved by Mansoura Faculty of Medicine – Institutional Review Board with the registration (MD.20.07.344.R1.R2); informed consent was obtained from the parents of study participants prior to enrollment in the study, confidentiality and personal privacy were respected at all levels of the study, and collected data will not be used for any other purpose. Full trial protocol can be accessed through contacting the co-author via the email. The authors declare no conflicts of interest. Competing interests: The authors declare no competing interests.

References

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