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

• ClinicalTrials.gov Identifier: NCT03513146
• Recruitment Status: Completed
• First Posted: May 1, 2018
• Last Update Posted: June 16, 2020
• Sponsor: Mansoura University Children Hospital
• Information provided by (Responsible Party): Nehad Nasef, Mansoura University Children Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Infant; Neonatal SEPSIS; Neonatal Feeding Disorder	Procedure: Oropharyngeal Administration of Mother's Milk (OPAMM)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Oropharyngeal Administration of mother's milk (OPAMM)
• Masking: Single (Outcomes Assessor)
• Masking Description: Microbiological assessment of bacterial colonization of the oropharyngeal cavity and the GIT will be masked
• Primary Purpose: Prevention
• Official Title: Impact of Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Hospital Acquired Neonatal Infection
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: December 1, 2018
• Actual Study Completion Date: December 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hospital Acquired late onset neonatal sepsis [ Time Frame: Neonatal care unit admission ]
   Culture proven neonatal sepsis acquired during neonatal care admission

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 90 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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.

Contacts and Locations

Locations

Egypt

Mansoura University Children Hospital

Mansourah, El Dakahlya, Egypt, 35111

Sponsors and Collaborators

Mansoura University Children Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Nehad Nasef, Professor of Pediatrics, Mansoura University Children Hospital
• ClinicalTrials.gov Identifier: NCT03513146
• Other Study ID Numbers: MS-15.09.03
• First Posted: May 1, 2018
• Last Update Posted: June 16, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neonatal Sepsis; Premature Birth; Feeding and Eating Disorders; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sepsis; Infant, Newborn, Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Mental Disorders