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Clinical Trials/NCT03513146
NCT03513146
Completed
Not Applicable

Impact of Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Hospital Acquired Neonatal Infection

Mansoura University Children Hospital1 site in 1 country200 target enrollmentMay 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Mansoura University Children Hospital
Enrollment
200
Locations
1
Primary Endpoint
Hospital Acquired late onset neonatal sepsis
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
December 1, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mansoura University Children Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nehad Nasef

Professor of Pediatrics

Mansoura University Children Hospital

Eligibility Criteria

Inclusion Criteria

  • Preterm infants delivered at less than 32 weeks gestation and less than 1500 grams birth weight will be included in the study

Exclusion Criteria

  • Preterm infants \< 32 weeks gestation unable to be fed on own mothers' colostrum or milk.
  • Preterm infants with major congenital anomalies or chromosomal abnormalities.
  • Preterm infants delivered to mothers with confirmed chorioamnionitis
  • Preterm infants with confirmed early onset sepsis.

Outcomes

Primary Outcomes

Hospital Acquired late onset neonatal sepsis

Time Frame: Neonatal care unit admission

Culture proven neonatal sepsis acquired during neonatal care admission

Secondary Outcomes

  • Colonization of the oro-pharyngeal pouch with pathogenic micro-organism(Neonatal care unit admission)
  • Colonization of the GIT with pathogenic micro-organism(Neonatal care unit admission)
  • Necrotizing enterocolitis(Neonatal care unit admission)
  • Ventilator associated pneumonia(Neonatal care unit admission)

Study Sites (1)

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