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Completed

NCT Number: NCT03552510

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

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.

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Key information

Age range

1 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Acronym: OPAMM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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