Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection

Not Applicable

Completed

• Conditions: Neonatal SEPSIS; Preterm Infant; Neonatal Feeding Disorder

• Registration Number: NCT03513146
• Lead Sponsor: Mansoura University Children Hospital

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital Acquired late onset neonatal sepsis	Neonatal care unit admission	Culture proven neonatal sepsis acquired during neonatal care admission

Secondary Outcome Measures

Name	Time	Method
Colonization of the oro-pharyngeal pouch with pathogenic micro-organism	Neonatal care unit admission	Throat swab will be taken at the start of the study and at the end of full enteral feeding.
Colonization of the GIT with pathogenic micro-organism	Neonatal care unit admission	Stool culture will be taken at the start of the study and at the end of full enteral feeding.
Necrotizing enterocolitis	Neonatal care unit admission	Bell's stage II of necrotizing enterocolitis
Ventilator associated pneumonia	Neonatal care unit admission	Clinical and radiological evidence of Ventilator associated pneumonia

Trial Locations

Locations (1)

Mansoura University Children Hospital; 🇪🇬 Mansourah, El Dakahlya, Egypt