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Completed

NCT Number: NCT03513146

Oropharyngeal Administration of Mother's Milk in Preterm Infants and 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.

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Key information

Conditions

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

Age range

1 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Hospital Acquired late onset neonatal sepsis

    Time frame: Neonatal care unit admission

    Culture proven neonatal sepsis acquired during neonatal care admission

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Acronym: OPAMM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 1, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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