Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection
Condition: Preterm Infant; Neonatal SEPSIS; Neonatal Feeding Disorder
MeSH terms: Neonatal Sepsis; Premature Birth; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The protective effect of mother's milk and colostrum on oropharyngeal cavity is not
      achievable with gavage feeding. This may be increase the risk of colonization of the
      oropharyngeal cavity with pathogenic bacteria and subsequent increase in the risk of neonatal
      sepsis. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM)
      before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm
      infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM
      on the incidence of nosocomial sepsis.
    

Detailed description: 
      Preterm, very low Birth Weight (VLBW), infants are at increased risk of feeding intolerance
      as they have shorter GIT with lower digestive, absorptive and motility capabilities than
      those of full term infants. Intolerance to enteral feeding has been associated with abdominal
      distention, initiation of an inflammatory cascade, edema of the bowel, and subsequent
      development of necrotizing enterocolitis (NEC).

      Oral feeding is the best and physiologic method for enteral nutrition of preterm infants.
      However, because of immaturity of suckling reflex and poor coordination between suckling and
      swallowing, gavage (oro-gastric or nasogastric tube feeding) has been used as an alternative
      method of enteral nutrition in preterm infants.

      The gut of preterm infants is frequently colonized with pathogenic bacteria due to
      prematurity, increase gut mucosal permeability, delayed initiation of feeding, formula
      feeding, and frequent use of antibiotics. This pathogenic bacteria increase the chance of
      development of nosocomial acquired sepsis and NEC.

      Mother's milk, particularly colostrum, is rich in cytokines and other immune agents that
      provide bacteriostatic, bacteriocidal, antiviral, anti-inflammatory and immunomodulatory
      protective agents against infection. Thus early gut priming and initiation of enteral feeding
      of preterm infants with mother's colostrum and milk decrease pathogenic bacterial
      colonization and subsequent development of sepsis and NEC.

      During breast feeding, mother's milk comes in contact with the mouth and oro-pharyngeal pouch
      which, theoretically, stimulate both oropharyngeal receptors that improves the motility,
      secretory and absorptive ability of the GIT. Furthermore, anti-inflammatory and pro
      inflammatory cytokines, which are present abundantly in mother's colostrum and milk, may
      exert an immuno-protective effect when they come in contact with oropharyngeal as well as GIT
      mucosa.

      We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before
      gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with
      pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the
      incidence of nosocomial sepsis.
    

Intervention name(s): Oropharyngeal Administration of Mother's Milk (OPAMM)
Intervention type(s): Procedure
Intervention description(s): 0.2 ml of own mother's milk will be given by dropper to the oro-pharyngeal pouch, tongue and cheeks and the remaining amount will be given by the regular gavage feeding on intervals and amount regulated by the feeding protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Oropharyngeal Administration of mother's milk (OPAMM)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention