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

Preterm Infant Clinical Trial

— OPAMM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513146
• Other study ID #: MS-15.09.03
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2020
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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.

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Neonatal Feeding Disorder
• Neonatal SEPSIS
• Premature Birth
• Preterm Infant

Intervention

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

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansourah	El Dakahlya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Acquired late onset neonatal sepsis	Culture proven neonatal sepsis acquired during neonatal care admission	Neonatal care unit admission
Secondary	Colonization of the oro-pharyngeal pouch with pathogenic micro-organism	Throat swab will be taken at the start of the study and at the end of full enteral feeding.	Neonatal care unit admission
Secondary	Colonization of the GIT with pathogenic micro-organism	Stool culture will be taken at the start of the study and at the end of full enteral feeding.	Neonatal care unit admission
Secondary	Necrotizing enterocolitis	Bell's stage II of necrotizing enterocolitis	Neonatal care unit admission
Secondary	Ventilator associated pneumonia	Clinical and radiological evidence of Ventilator associated pneumonia	Neonatal care unit admission