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

Sponsor

Mansoura University Children Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03552510

Collaborator

(none)

Enrollment

Location

Arms

30.9

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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	N/A

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

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Oropharyngeal Administration of mother's milk (OPAMM)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 :

Jun 1, 2016

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Dec 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)

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

Motilin hormone [24 hours]
Plasma Motilin hormone level
Gastrin hormone [24 hours]
Plasma Gastrin hormone level
Secretin hormone [24 hours]
Plasma Secretin hormone level
Cholecystokinin [24 hours]
Plasma Cholecystokinin hormone level

Secondary Outcome Measures

Feeding residual [24 hours]
Percentage of feeding residual after each fed
Holding feeds [24 hours]
Frequency of withholding feeds for suspected feeding intolerance

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 60 Days

Sexes Eligible for Study:

All

Accepts 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Children Hospital	Mansourah	El Dakahlya	Egypt	35111

Sponsors and Collaborators

Mansoura University Children Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 12, 2018

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Disease

Feeding and Eating Disorders

Study Results

No Results Posted as of Mar 15, 2021