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Clinical Trials/NCT03552510
NCT03552510
Completed
Not Applicable

Impact of Oro-Pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on GIT Motility in Preterm Infants

Mansoura University Children Hospital1 site in 1 country20 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Mansoura University Children Hospital
Enrollment
20
Locations
1
Primary Endpoint
Cholecystokinin
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Mother's milk does not come in contact with the oropharyngeal pouch of preterm infants during gavage feeding. We hypothesized that stimulation of the oropharyngeal pouch using small amount of the mother's milk 5 minutes before initiation of regular gavage feeding will increase the level of GIT hormones.

Detailed Description

Feeding preterm infants continues to challenge health care providers because of difficulty to provide adequate volume of milk that maintains optimum nutrition without increasing the risk of feeding intolerance. Preterm, 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 inflammatory cascade, edema of the bowel, and subsequent development of necrotizing enterocolitis. Oral feeding is the best physiologic method for enteral nutrition of preterm infants. However, because of immaturity of suckling reflex and poor coordination between suckling and swallowing, gavage feeding (oro-gastric or naso-gastric tube feeding) has been used an alternative method of enteral nutrition in preterm infants. During breastfeeding, mother's milk comes in contact with mouth and oro-pharyngeal pouch which, theoretically, stimulates both oro-pharyngeal 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 oro-pharyngeal as well as GIT mucosa. Preterm, VLBW, infant in the NICU receives enteral feedings by a naso-gastric or oro-gastric gavage tube. Thus, mother's milk does not typically come into contact with oro-pharyngeal pouch which delays the maturation of oral suckling and swallowing skills in preterm infants. Oral stimulation has been shown to improve oral feeding performance, attain early oral feeding, improve weight gain and shorten the length of hospital stay. Investigators aimed to study the effect of Oro-pharyngeal administration of mother's milk before regular gavage feeding on gastrointestinal movement in preterm infants.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
December 30, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Mansoura University Children Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nehad Nasef

Professor of Pediatrics

Mansoura University Children Hospital

Eligibility 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

  • Preterm infants \> 32 weeks gestation unable to be fed on own mother's 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.

Outcomes

Primary Outcomes

Cholecystokinin

Time Frame: 24 hours

Plasma Cholecystokinin hormone level

Motilin hormone

Time Frame: 24 hours

Plasma Motilin hormone level

Secretin hormone

Time Frame: 24 hours

Plasma Secretin hormone level

Gastrin hormone

Time Frame: 24 hours

Plasma Gastrin hormone level

Secondary Outcomes

  • Holding feeds(24 hours)
  • Feeding residual(24 hours)

Study Sites (1)

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