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

NCT03552510 | Completed

• 1 other identifier: MS.15.06.01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Feeding Disorder Neonatal; Gastrointestinal Motility Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Feeding residual

  24 hours

• Holding feeds

  24 hours

Study Arms (2)

Initial OPAMM

ACTIVE COMPARATOR

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

Initial Gavage

ACTIVE COMPARATOR

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

Interventions

Oro-pharyngeal Administration of Mother's Milk PROCEDURE

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)

Initial Gavage; Initial OPAMM

Eligibility Criteria

• Age: 1 Day - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants delivered at less than 32 weeks gestation and less than 1500 grams birth weight will be included in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory assessment of GIT hormonal level will be masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Oropharyngeal Administration of mother's milk (OPAMM)

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: June 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

EG (1)