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

Mansoura University Children Hospital

Status: Completed

Conditions: Neonatal Feeding Disorder; Preterm Infant; Neonatal SEPSIS

Treatments: Procedure: Oropharyngeal Administration of Mother's Milk (OPAMM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03513146

MS-15.09.03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 1 to 90 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

OPAMM group

Experimental group

Description:

During the pre-feeding period, infants will receive mother's colostrum (to the maximum of 0.2 ml) by dropper to the oro-pharyngeal pouch, tongue and cheeks every 2 to 4 hours. When an infant fits the criteria to start enteral feeding, 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. This practice will be continued till the infants reach full oral feeding.

Treatment:

Procedure: Oropharyngeal Administration of Mother's Milk (OPAMM)

Control Group

No Intervention group

Description:

During the pre-feeding period, preterm infants will remain NPO. When an infant fits the criteria to start enteral feeding, own mother's colostrum or milk will be given by the regular gavage feeding on intervals regulated by the feeding protocol. This practice will be continued till the infants reach full oral feeding.