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

NCT03513146 | Completed

• 1 other identifier: MS-15.09.03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Neonatal SEPSIS; Neonatal Feeding Disorder

Outcome Measures

Primary Outcomes (1)

• Hospital Acquired late onset neonatal sepsis

  Culture proven neonatal sepsis acquired during neonatal care admission

  Neonatal care unit admission

Secondary Outcomes (4)

• Colonization of the oro-pharyngeal pouch with pathogenic micro-organism

  Neonatal care unit admission

• Colonization of the GIT with pathogenic micro-organism

  Neonatal care unit admission

• Necrotizing enterocolitis

  Neonatal care unit admission

• Ventilator associated pneumonia

  Neonatal care unit admission

Study Arms (2)

OPAMM group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

Interventions

Oropharyngeal Administration of Mother's Milk (OPAMM) PROCEDURE

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

OPAMM group

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants delivered at less than 32 weeks gestation and less than 1500 grams birth weight will be included in the study

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

Related Publications (1)

• 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.

  PMID: 31147686 DERIVED

MeSH Terms

Conditions

Premature Birth; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Microbiological assessment of bacterial colonization of the oropharyngeal cavity and the GIT will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Oropharyngeal Administration of mother's milk (OPAMM)

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

EG (1)