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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Neonatal SEPSIS; Neonatal Feeding Disorder
• Intervention / Treatment: Procedure: Oropharyngeal Administration of Mother's Milk (OPAMM)

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Dakahlya
    • Mansourah, El Dakahlya, Egypt, 35111
      • Mansoura University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPAMM group; 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.	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
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Acquired late onset neonatal sepsis	Culture proven neonatal sepsis acquired during neonatal care admission	Neonatal care unit admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Necrotizing enterocolitis	Bell's stage II of necrotizing enterocolitis	Neonatal care unit admission
Ventilator associated pneumonia	Clinical and radiological evidence of Ventilator associated pneumonia	Neonatal care unit admission

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital

Publications and helpful links

General Publications

• Panchal H, Athalye-Jape G, Patole S. Oropharyngeal Colostrum for Preterm Infants: A Systematic Review and Meta-Analysis. Adv Nutr. 2019 Nov 1;10(6):1152-1162. doi: 10.1093/advances/nmz033.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Feeding and Eating Disorders; Premature Birth; Neonatal Sepsis
• Other Study ID Numbers: MS-15.09.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No