Protocol summary

Study aim
The effect of oral-pharyngeal breastfeeding until the onset of oral feeding in premature infants on nutritional outcomes
Design
Excel software rand function was used to randomize a clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 80 infants.
Settings and conduct
Infants of 30-25 weeks were admitted to the NICU of Amir Al-Momenin Hospital in Semnan. Each infant will be randomly assigned to the breast milk group or placebo in a ratio of 1: 1. Using aseptic techniques, one researcher prepares insulin syringes with 0.1 ml of sterile BM or distilled water. The syringes are covered with a matte coating to prevent them from becoming blind. The baby's name is placed on the syringe, and a separate box is placed to store the milk syringes of each baby in the refrigerator and maintain the box blindness for the babies in the control group. Each infant will receive 0.2 ml of BM or sterile distilled water every 2 hours until the start of oral feeding, regardless of intestinal milk intake. At each turn, the contents of a syringe are poured to the right of the oral cavity. After 30 s, the contents of the second syringe are poured to the left.
Participants/Inclusion and exclusion criteria
Infants with a gestational age of 25-30 weeks and infants with congenital malformations of the gastrointestinal tract, urinary, renal systems or need a ventilator, a history of substance abuse or HIV infection in the mother, and mothers who are not breastfed are excluded.
Intervention groups
Starting 48 to 72 hours after the birth of each baby, every two hours, warm each syringe for 5 minutes in the incubator and then pour the contents of one syringe to the right of the oral cavity and after 30 s, pour the contents of the second syringe to the left.
Main outcome variables
Lavage, time of discharge from hospital, the onset of intestinal feeding, and oral feeding.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220509054798N1
Registration date: 2022-05-21, 1401/02/31
Registration timing: prospective

Last update: 2022-05-21, 1401/02/31
Update count: 0
Registration date
2022-05-21, 1401/02/31
Registrant information
Name
Fatemeh Kelich
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3330 1998
Email address
fatemehkelich1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oropharyngeal mother’s milk until the beginning of oral feeding in preterm infants on nutritional outcomes
Public title
The effect of oropharyngeal mother’s milk until the beginning of oral feeding in preterm infants on nutritional outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 25 to 30 weeks
Exclusion criteria:
Requires a ventilator Having a congenital disease Substance abuse by the infant's mother The mother of the infant is infected with HIV
Age
From 1 day old to 2 months old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated randomization will hide from all physicians, physicians, nurses, parents, and placebo and breastfeeding physicians.
Blinding (investigator's opinion)
Double blinded
Blinding description
Insulin syringes will be used to administer breast milk. One researcher then uses aseptic techniques to prepare insulin syringes with 0.1 ml of sterile breast milk or distilled water. It then labels the syringes and seals them with a matte finish to prevent them from becoming blind. The baby's name is then written on the syringe again. There will be a separate box for each baby to store milk syringes inside the refrigerator shelf and a box for babies in the control group for syringes containing distilled water to be blinded.
Placebo
Used
Assignment
Parallel
Other design features
In other studies, only colostrum was used for a limited time, and its effects on safety issues were investigated. In contrast, breast milk was used in this study and continued until oral feeding.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Unit 2, Jahan complex, Hakim Elahi 60 street, Hakim Elahi Blvd, Semsnan, Semnan.
City
Semnan
Province
Semnan
Postal code
3515611979
Approval date
2022-02-02, 1400/11/13
Ethics committee reference number
IR.MUBABOL.REC.1400.281

Health conditions studied

1

Description of health condition studied
Nutritional tolerance in premature infants
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nutritional tolerance
Timepoint
Every two hours
Method of measurement
Residual gastric volume

Secondary outcomes

1

Description
Time to start intestinal feeding
Timepoint
The day of feeding by gavage
Method of measurement
day

Intervention groups

1

Description
Intervention group: Administration of breast milk at the rate of 0.2 ml every 2 hours by the oropharyngeal method
Category
Other

2

Description
Control group: Administration of 0.2 ml sterile distilled water every 2 hours by oropharyngeal method
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Fatemeh Kelich
Street address
Amir Al-Momenin Hospital, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0066
Email
amir.hospital@semums.ac.ir
Web page address
https://amirhos.semums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Hossein Najafzadeh Varzi
Street address
Unit 02, Jahan complex, Hakim Elahi 60 street, Hakim Elahi boulevard, Semnan, Semnan
City
Semnan
Province
Semnan
Postal code
35188257678
Phone
+98 23 3330 1998
Email
fatemehkelich1990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Kelich
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 02, Jahan complex, Hakim Elahi 60 street, Hakim Elahi boulevard, Semnan, Semnan
City
Semnan
Province
Semnan
Postal code
35188257678
Phone
+98 23 3330 1998
Email
fatemehkelich1990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyedeh Roghayeh Jafarian Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran, Babol, Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
۰۱۱-۳۲۱۹۹۵۹۲-۵
Email
jafarianamiri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Kelich
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 02, Jahan complex, Hakim Elahi 60 street, Hakim Elahi boulevard, Semnan, Semnan
City
Semnan
Province
Semnan
Postal code
۳۵۱۸۸۲۵۷۶۷۸
Phone
+98 23 3330 1998
Email
fatemehkelich1990@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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