Clinical trial NCT03552510: Oropharyngeal Administration of Mother's Milk in Preterm Infants and Gastrointestinal Motility
Official title: Impact of Oro-Pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on GIT Motility in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Feeding Disorder Neonatal
Gastrointestinal Motility Disorder
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Oropharyngeal Administration of mother's milk (OPAMM)
Primary purpose: SUPPORTIVE_CARE

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.

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:

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

Primary outcomes:
measure: Motilin hormone
timeFrame: 24 hours
measure: Gastrin hormone
timeFrame: 24 hours
measure: Secretin hormone
timeFrame: 24 hours
measure: Cholecystokinin
timeFrame: 24 hours
Secondary outcomes:
measure: Feeding residual
timeFrame: 24 hours
measure: Holding feeds
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Children Hospital
state: El Dakahlya
Study officials:
References: