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Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection (OPAMM)

Primary Purpose

Preterm Infant, Neonatal SEPSIS, Neonatal Feeding Disorder

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

About this trial

This is an interventional prevention trial for Preterm Infant

Eligibility Criteria

1 Day - 90 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 mothers' 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

Experimental

No Intervention

Arm Label

OPAMM group

Control Group

Arm Description

During the pre-feeding period, infants will receive mother's colostrum (to the maximum of 0.2 ml) by dropper to the oro-pharyngeal pouch, tongue and cheeks every 2 to 4 hours. When an infant fits the criteria to start enteral feeding, 0.2 ml of own mother's milk will be given by dropper to the oro-pharyngeal pouch, tongue and cheeks and the remaining amount will be given by the regular gavage feeding on intervals and amount regulated by the feeding protocol. This practice will be continued till the infants reach full oral feeding.

During the pre-feeding period, preterm infants will remain NPO. When an infant fits the criteria to start enteral feeding, own mother's colostrum or milk will be given by the regular gavage feeding on intervals regulated by the feeding protocol. This practice will be continued till the infants reach full oral feeding.

Outcomes

Primary Outcome Measures

Hospital Acquired late onset neonatal sepsis
Culture proven neonatal sepsis acquired during neonatal care admission

Secondary Outcome Measures

Colonization of the oro-pharyngeal pouch with pathogenic micro-organism
Throat swab will be taken at the start of the study and at the end of full enteral feeding.
Colonization of the GIT with pathogenic micro-organism
Stool culture will be taken at the start of the study and at the end of full enteral feeding.
Necrotizing enterocolitis
Bell's stage II of necrotizing enterocolitis
Ventilator associated pneumonia
Clinical and radiological evidence of Ventilator associated pneumonia

Full Information

First Posted
April 19, 2018
Last Updated
June 15, 2020
Sponsor
Mansoura University Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03513146
Brief Title
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection
Acronym
OPAMM
Official Title
Impact of Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Hospital Acquired Neonatal Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 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
The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent increase in the risk of neonatal sepsis. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the incidence of nosocomial sepsis.
Detailed Description
Preterm, very low Birth Weight (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 an inflammatory cascade, edema of the bowel, and subsequent development of necrotizing enterocolitis (NEC). Oral feeding is the best and physiologic method for enteral nutrition of preterm infants. However, because of immaturity of suckling reflex and poor coordination between suckling and swallowing, gavage (oro-gastric or nasogastric tube feeding) has been used as an alternative method of enteral nutrition in preterm infants. The gut of preterm infants is frequently colonized with pathogenic bacteria due to prematurity, increase gut mucosal permeability, delayed initiation of feeding, formula feeding, and frequent use of antibiotics. This pathogenic bacteria increase the chance of development of nosocomial acquired sepsis and NEC. Mother's milk, particularly colostrum, is rich in cytokines and other immune agents that provide bacteriostatic, bacteriocidal, antiviral, anti-inflammatory and immunomodulatory protective agents against infection. Thus early gut priming and initiation of enteral feeding of preterm infants with mother's colostrum and milk decrease pathogenic bacterial colonization and subsequent development of sepsis and NEC. During breast feeding, mother's milk comes in contact with the mouth and oro-pharyngeal pouch which, theoretically, stimulate both oropharyngeal 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 oropharyngeal as well as GIT mucosa. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the incidence of nosocomial sepsis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Oropharyngeal Administration of mother's milk (OPAMM)
Masking
Outcomes Assessor
Masking Description
Microbiological assessment of bacterial colonization of the oropharyngeal cavity and the GIT will be masked
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPAMM group
Arm Type
Experimental
Arm Description
During the pre-feeding period, infants will receive mother's colostrum (to the maximum of 0.2 ml) by dropper to the oro-pharyngeal pouch, tongue and cheeks every 2 to 4 hours. When an infant fits the criteria to start enteral feeding, 0.2 ml of own mother's milk will be given by dropper to the oro-pharyngeal pouch, tongue and cheeks and the remaining amount will be given by the regular gavage feeding on intervals and amount regulated by the feeding protocol. This practice will be continued till the infants reach full oral feeding.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
During the pre-feeding period, preterm infants will remain NPO. When an infant fits the criteria to start enteral feeding, own mother's colostrum or milk will be given by the regular gavage feeding on intervals regulated by the feeding protocol. This practice will be continued till the infants reach full oral feeding.
Intervention Type
Procedure
Intervention Name(s)
Oropharyngeal Administration of Mother's Milk (OPAMM)
Intervention Description
0.2 ml of own mother's milk will be given by dropper to the oro-pharyngeal pouch, tongue and cheeks and the remaining amount will be given by the regular gavage feeding on intervals and amount regulated by the feeding protocol
Primary Outcome Measure Information:
Title
Hospital Acquired late onset neonatal sepsis
Description
Culture proven neonatal sepsis acquired during neonatal care admission
Time Frame
Neonatal care unit admission
Secondary Outcome Measure Information:
Title
Colonization of the oro-pharyngeal pouch with pathogenic micro-organism
Description
Throat swab will be taken at the start of the study and at the end of full enteral feeding.
Time Frame
Neonatal care unit admission
Title
Colonization of the GIT with pathogenic micro-organism
Description
Stool culture will be taken at the start of the study and at the end of full enteral feeding.
Time Frame
Neonatal care unit admission
Title
Necrotizing enterocolitis
Description
Bell's stage II of necrotizing enterocolitis
Time Frame
Neonatal care unit admission
Title
Ventilator associated pneumonia
Description
Clinical and radiological evidence of Ventilator associated pneumonia
Time Frame
Neonatal care unit admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
90 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 mothers' 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
Citations:
PubMed Identifier
31147686
Citation
Panchal H, Athalye-Jape G, Patole S. Oropharyngeal Colostrum for Preterm Infants: A Systematic Review and Meta-Analysis. Adv Nutr. 2019 Nov 1;10(6):1152-1162. doi: 10.1093/advances/nmz033.
Results Reference
derived

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Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection

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