Randomized Controlled Trial of Oral Immunotherapy with Colostrum or Breast Milk and Clinical Outcomes among Preterm Babies

Document Type : Original Article


1 Neonatal Department, Adan Hospital, Ministry of Health, Kuwait

2 Department of OBG Nursing, Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Manipal, India.

3 Manipal College of Nursing, Manipal, Kuwait


Background: It is well known that mother’s milk is the best nutrient for the baby. Some formal studies have investigated its effectiveness and supported it as a safe feasible practice. The effects on other variables are vague since the evidence is not strong to observe significant differences in the outcomes, such as necrotizing enterocolitis (NEC), sepsis, length of hospital stay, and mortality. 
The present study was carried out to assess the effect of oral therapy with colostrum or breast milk on the clinical outcomes using a questionnaire on clinical outcomes.
Methods: A total of 48 babies were randomly assigned to receive 0.2 ml of their own mother’s colostrum, breast milk, or sterile water via oropharyngeal route every 4 h, and it was continued till the baby independently could suck via bottle or breast. The babies were followed since admission until discharge by the unit.
Results: According to the obtained results, there was no statistical difference among the preterm babies who received oral immunotherapy with colostrum, breast milk, and sterile water regarding the clinical outcomes, such as NEC, culture-proven late-onset sepsis, intraventricular hemorrhage, retinopathy of prematurity, chronic lung disease, jaundice, and mortality. The oral therapy with colostrum was observed to have a significant influence on age at discharge (P=0.02).
Conclusion: Oral therapy with colostrum is an alternative method of providing mothers’ milk for babies who are kept nil per oral. Oral therapy with colostrum or breast milk leads to earlier weeks of discharge.


  1. Gephart S, Weller M. Colostrum as oral immune therapy to promote neonatal health. Adv Neonatal Care. 2014; 14(1):44-51.
  2. Romano-Keeler J, Azcarate-Peril M, Weitkamp J, Slaughter JC, McDonald WH, Meng S, et al. Oral colostrum priming shortens hospitalization without changing the immunomicrobial milieu. J Perinatol. 2016; 37(1):36-41.
  3. Castellote C, Casillas R, Ramírez-Santana C, Pérez-Cano FJ, Castell M, Moretones MG, et al. Premature delivery influences the immunological composition of colostrum and transitional and mature human milk. J Nutr. 2011; 141(6):1181-7.
  4. Goldman A, Garza C, Nichols B, Johnson CA, Smith EO, Goldblum RM. Effects of prematurity on the immunologic system in human milk. J Pediatr. 1982; 101(6):901-5.
  5. Ballard O, Morrow A. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013; 60(1):49-74.
  6. Grumach A, Carmona R, Lazarotti D, Ribeiro MA, Rozentraub RB, Racz ML, et al. Immunological factors in milk from Brazilian mothers delivering small-for-date term neonates. Acta Paediatr. 1993; 82(3):284-90.
  7. el-Mohandes AE, Picard MB, Simmens SJ, Keiser JF. Use of human milk in the intensive care nursery decreases the incidence of nosocomial sepsis. J Perinatol. 1997; 17(2):130-4.
  8. Furman L, Taylor G, Minich N, Hack M. The effect of maternal milk on neonatal morbidity of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2003; 157(1):66-71.
  9. Hylander M, Strobino D, Dhanireddy R. Human milk feedings and infection among very low birth weight infants. Pediatrics. 1998; 102(3):E38.

10. Gephart S, Weller M. Colostrum as oral immune therapy to promote neonatal health. Adv Neonatal Care. 2014; 14(1):44-51.

11. Schanler RJ. Outcomes of Human Milk-Fed Premature Infants. Seminars in Perinatology. 2011; 35 (1): 29-3312.

12. Mathur NB, Dwarkadas AM, Sharma VK, Saha K, Jain N. Anti-infective factors in preterm human colostrum. Acta Paediatr. 1990; 79(11):1039-44.

13. Rodriguez NA, Meier PP, Groer M, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol 2009; 29(1):1-7.

14. Buescher ES. Anti-inflammatory characteristics of human milk: how, where and why. Adv Exp Med Biol. 2001; 501:207-22.

15. Buescher ES, Malinowska I. Soluble receptors and cytokine antagonists in human milk. Pediatr Res. 1996; 40(6):839-44.

16. Buescher ES, McWilliams-Koeppen P. Soluble tumor necrosis factor-alpha (TNF-alpha) receptors in human colostrum and milk bind to TNF-alpha and neutralize TNF-alpha bioactivity. Pediatr Res. 1998; 44(1):37-42.

17. Garofalo RP, Goldman AS. Cytokines, chemokines and colony-stimulating factors in human milk: the 1997 update. Biol Neonate. 1998; 74(2):134-42.

18. Rodríguez NA, Miracle DJ, Meier PP. Sharing the science on human milk feedings with mothers of very low birth weight infants. J Obstet Gynecol Neonatal Nurs. 2005; 34(1):109-19.

19. Roitt I, Brostoff J, Male D. Immunology. 6th ed. New York: Harcourt (Publisher); 2001.

20. Benjamini E, Sunshine G, Leskowitz S. Immunology. A short course. New York: Wiley-Liss; 1996.

21. La Gamma EF, Brown LE. Feeding practices for infants weighing less than 1500 g at birth and the pathogenesis of necrotizing enterocolitis. Clin Perinatol. 1994; 21(2):271-306.

22. Westerbeek E, Van den Berg A, Lafeber HN, Knol J, Fetter WP, van Elburg RM. The intestinal bacterial colonization in preterm infants: a review of the literature. Clin Nutr. 2006; 25(3):361-8.

23. Montgomery DP, Baer VL, Lambert DK, Christensen RD. Oropharyngeal administration of colostrum to very low birth weight infants: results of a feasibility trial. Neonatal Intensive Care. 2010; 23(1):27-9.

24. Rodriguez NA, Groer MW, Zeller JM, Engstrom JL, Fogg L, Du H, et al. A randomized controlled trial of the oropharyngeal administration of mother’s colostrum to extremely low birth weight infants in the first days of life. Neonatal Intensive Care. 2011; 24(4):31-5.  

25. Rodriguez NA, Meier PP, Groer MW, Zeller JM, Engstrom JL, Fogg L. A pilot study to determine the safety and feasibility of oropharyngeal administration of own mother’s colostrum to extremely low birth weight infants. Adv Neonatal Care. 2010; 10(4):206.