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

Impact of Oro-Pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on GIT Motility in Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03552510
Acronym
OPAMM
Enrollment
20
Registered
2018-06-12
Start date
2016-06-01
Completion date
2018-12-30
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Disorder Neonatal, Gastrointestinal Motility Disorder, Preterm Infant

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.

Interventions

PROCEDUREOro-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)

Sponsors

Mansoura University Children Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Laboratory assessment of GIT hormonal level will be masked

Intervention model description

Oropharyngeal Administration of mother's milk (OPAMM)

Eligibility

Sex/Gender
ALL
Age
1 Days to 60 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Motilin hormone24 hoursPlasma Motilin hormone level
Gastrin hormone24 hoursPlasma Gastrin hormone level
Secretin hormone24 hoursPlasma Secretin hormone level
Cholecystokinin24 hoursPlasma Cholecystokinin hormone level

Secondary

MeasureTime frameDescription
Feeding residual24 hoursPercentage of feeding residual after each fed
Holding feeds24 hoursFrequency of withholding feeds for suspected feeding intolerance

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026