Oropharyngeal Administration of Mother's Milk in Preterm Infants and Gastrointestinal Motility

Preterm Infant Clinical Trial

— OPAMM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552510
• Other study ID #: MS.15.06.01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2021
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Gastrointestinal Motility Disorder
• Premature Birth
• Preterm Infant

Intervention

Procedure:
• Oro-pharyngeal Administration of Mother's Milk
Infants will receive mother's milk (to the maximum of 0.2 ml ) by dropper to the oro-pharyngeal pouch, tongue and cheeks every 3 hours (5 minutes before time of feeding)

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansourah	El Dakahlya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motilin hormone	Plasma Motilin hormone level	24 hours
Primary	Gastrin hormone	Plasma Gastrin hormone level	24 hours
Primary	Secretin hormone	Plasma Secretin hormone level	24 hours
Primary	Cholecystokinin	Plasma Cholecystokinin hormone level	24 hours
Secondary	Feeding residual	Percentage of feeding residual after each fed	24 hours
Secondary	Holding feeds	Frequency of withholding feeds for suspected feeding intolerance	24 hours