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

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ClinicalTrials.gov Identifier: NCT03552510
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Nehad Nasef, Mansoura University Children Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

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)




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552510


Locations
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Egypt
Mansoura University Children Hospital Recruiting
Mansourah, El Dakahlya, Egypt, 35111
Contact: nehad a nasef, MD    01001229299 ext 002    nehad_nasef@yahoo.com   
Sponsors and Collaborators
Mansoura University Children Hospital

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Responsible Party: Nehad Nasef, Professor of Pediatrics, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT03552510     History of Changes
Other Study ID Numbers: MS.15.06.01
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Disease
Feeding and Eating Disorders
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Mental Disorders