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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Feeding Disorder Neonatal; Gastrointestinal Motility Disorder
• Intervention / Treatment: Procedure: Oro-pharyngeal Administration of Mother's Milk

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Dakahlya
    • Mansourah, El Dakahlya, Egypt, 35111
      • Mansoura University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Initial OPAMM; At the start of the study, infants will receive mother's milk (to the maximum of 0.2 ml) to the oro-pharyngeal pouch, tongue and cheeks every 3 hours (5 minutes before time of feeding), and the remaining amount will be given by regular gavage feeding for 24 hours. Then, infants will receive regular gavage feeding only for the next 24 hours.	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)
ACTIVE_COMPARATOR: Initial Gavage; At the start of the study, infants will receive regular gavage feeding only for 24 hours. Then, 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), and the remaining amount will be given by regular gavage feeding for the next 24 hours.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motilin hormone	Plasma Motilin hormone level	24 hours
Gastrin hormone	Plasma Gastrin hormone level	24 hours
Secretin hormone	Plasma Secretin hormone level	24 hours
Cholecystokinin	Plasma Cholecystokinin hormone level	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding residual	Percentage of feeding residual after each fed	24 hours
Holding feeds	Frequency of withholding feeds for suspected feeding intolerance	24 hours

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Disease; Feeding and Eating Disorders; Premature Birth
• Other Study ID Numbers: MS.15.06.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No