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

• ClinicalTrials.gov Identifier: NCT03552510
• Recruitment Status: Completed
• First Posted: June 12, 2018
• Last Update Posted: March 15, 2021
• Sponsor: Mansoura University Children Hospital
• Information provided by (Responsible Party): Nehad Nasef, Mansoura University Children Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Infant; Feeding Disorder Neonatal; Gastrointestinal Motility Disorder	Procedure: Oro-pharyngeal Administration of Mother's Milk	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Oropharyngeal Administration of mother's milk (OPAMM)
• Masking: Single (Outcomes Assessor)
• Masking Description: Laboratory assessment of GIT hormonal level will be masked
• Primary Purpose: Supportive Care
• Official Title: Impact of Oro-Pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on GIT Motility in Preterm Infants
• Actual Study Start Date: June 1, 2016
• Actual Primary Completion Date: December 30, 2018
• Actual Study Completion Date: December 30, 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Motilin hormone [ Time Frame: 24 hours ]
   Plasma Motilin hormone level
2. Gastrin hormone [ Time Frame: 24 hours ]
   Plasma Gastrin hormone level
3. Secretin hormone [ Time Frame: 24 hours ]
   Plasma Secretin hormone level
4. Cholecystokinin [ Time Frame: 24 hours ]
   Plasma Cholecystokinin hormone level

Secondary Outcome Measures :

1. Feeding residual [ Time Frame: 24 hours ]
   Percentage of feeding residual after each fed
2. Holding feeds [ Time Frame: 24 hours ]
   Frequency of withholding feeds for suspected feeding intolerance

Eligibility Criteria

• Ages Eligible for Study: up to 60 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Mansoura University Children Hospital

Mansourah, El Dakahlya, Egypt, 35111

Sponsors and Collaborators

Mansoura University Children Hospital

More Information

• Responsible Party: Nehad Nasef, Professor of Pediatrics, Mansoura University Children Hospital
• ClinicalTrials.gov Identifier: NCT03552510
• Other Study ID Numbers: MS.15.06.01
• First Posted: June 12, 2018
• Last Update Posted: March 15, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Premature Birth; Disease; Feeding and Eating Disorders; Pathologic Processes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Mental Disorders