search
Back to results

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

Primary Purpose

Preterm Infant, Feeding Disorder Neonatal, Gastrointestinal Motility Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oro-pharyngeal Administration of Mother's Milk
Sponsored by
Mansoura University Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant

Eligibility Criteria

1 Day - 60 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Initial OPAMM

Initial Gavage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Motilin hormone
Plasma Motilin hormone level
Gastrin hormone
Plasma Gastrin hormone level
Secretin hormone
Plasma Secretin hormone level
Cholecystokinin
Plasma Cholecystokinin hormone level

Secondary Outcome Measures

Feeding residual
Percentage of feeding residual after each fed
Holding feeds
Frequency of withholding feeds for suspected feeding intolerance

Full Information

First Posted
May 29, 2018
Last Updated
March 12, 2021
Sponsor
Mansoura University Children Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03552510
Brief Title
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Gastrointestinal Motility
Acronym
OPAMM
Official Title
Impact of Oro-Pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on GIT Motility in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Children Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Feeding Disorder Neonatal, Gastrointestinal Motility Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Oropharyngeal Administration of mother's milk (OPAMM)
Masking
Outcomes Assessor
Masking Description
Laboratory assessment of GIT hormonal level will be masked
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial OPAMM
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Initial Gavage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Oro-pharyngeal Administration of Mother's Milk
Intervention Description
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)
Primary Outcome Measure Information:
Title
Motilin hormone
Description
Plasma Motilin hormone level
Time Frame
24 hours
Title
Gastrin hormone
Description
Plasma Gastrin hormone level
Time Frame
24 hours
Title
Secretin hormone
Description
Plasma Secretin hormone level
Time Frame
24 hours
Title
Cholecystokinin
Description
Plasma Cholecystokinin hormone level
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Feeding residual
Description
Percentage of feeding residual after each fed
Time Frame
24 hours
Title
Holding feeds
Description
Frequency of withholding feeds for suspected feeding intolerance
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
No
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: 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.
Facility Information:
Facility Name
Mansoura University Children Hospital
City
Mansourah
State/Province
El Dakahlya
ZIP/Postal Code
35111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs