Investigating the effect of changing body position on digestive tolerance in very low birth weight premature babies fed with enriched breast milk
Design
Clinical trial with two intervention groups, randomized, on 62 very low birth weight premature babies
Settings and conduct
The location of the neonatal special care department of Shahid Sadougi and Shahada Kargar Hospital in Yazd, the demographic information questionnaire of the newborn is completed. Babies are randomly assigned to two groups. In this study, enriched breast milk is given to the baby twice (8:00 am and 2:00 pm) and then in the first time, he is fed in the position of lying on his stomach and in the second time of feeding he is placed in the position of lying on his right side. Gastrointestinal tolerance is checked according to the checklist three hours after feeding, and a rest period (only breast milk is given) is considered between feeding with enriched breast milk. Also, other items related to digestive tolerance Including abdominal distention, the presence of vomiting is checked and recorded according to the checklist.
Participants/Inclusion and exclusion criteria
Entry criteria: 1- Premature baby weighing 1000-1500 grams
2- Fetal age 26-31 weeks
3- Oral feeding with nasogastric tube
4- Breastfeeding
5- Stability of clinical condition
6- Not being prohibited by the attending physician to lie down on the stomach and right side
Non-entry criteria: 1-Having congenital anomalies
2-Severe asphyxia
3-Having symptoms of digestive problems
Intervention groups
Very low birth weight preterm infants fed with fortified breast milk
Main outcome variables
Digestive tolerance of fortified breast milk
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230328057781N1
Registration date:2023-05-02, 1402/02/12
Registration timing:prospective
Last update:2023-05-02, 1402/02/12
Update count:0
Registration date
2023-05-02, 1402/02/12
Registrant information
Name
Marzieh Poorakrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3282 9120
Email address
m.poorakrami@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-10-17, 1402/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of body posture change on digestive tolerance in very low birth weight premature babies fed with enriched breast milk
Public title
The effect of changing body position on digestive tolerance of fortified breast milk in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature baby weighing 1000-1500 grams
Fetal age 26-31 weeks
Oral feeding with a nasogastric tube
Breast feeding
Stability of clinical condition
Not being forbidden by the attending physician to lie down on the stomach and right side
Exclusion criteria:
Having congenital abnormalities
severe asphyxia
Having symptoms of digestive problems
Age
From 182 days old to 217 days old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool
The file number of premature babies is written and placed in an envelope, and then by taking out the file number of each baby, they are placed in a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی یزد
Street address
صفاییه بلوار پرفسور حسابی
City
یزد
Province
Yazd
Postal code
891583135
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR. SSU.REC.1402.001
Health conditions studied
1
Description of health condition studied
Gastrointestinal intolerance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gastrointestinal intolerance
Timepoint
Measurement of digestive intolerance at the beginning of the study and 3 hours after feeding in lying positions on stomach and right side.
Method of measurement
Gastrointestinal intolerance checklist
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Very low birth weight premature babies fed with enriched breast milk are placed on their stomachs in the first feeding and after three hours the checklist related to digestive tolerance is completed for these babies and in the second feeding of these babies After feeding, he is placed on his right side and the checklist is completed three hours later. The second intervention group: very low birth weight premature babies fed with enriched breast milk are placed in the right side lying position in the first feeding, and three hours later the checklist is completed and in the next feeding, they are placed in the stomach lying position.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ssadoughi Hospital and Shohadai Kargar Hospita
Full name of responsible person
Marzieh Purakremi
Street address
Shahid Qandi Blvd, Ibn Sina Ave
City
yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargoui
Street address
Shahid Dr. Bahnar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
samat@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Marzieh Poorakremi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Ave , Dadgodtari st. 4th Alley
City
Abarkooh
Province
Yazd
Postal code
8931913497
Phone
+98 35 3282 9120
Email
mpoorakrami64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Hossein Lookzadeh
Position
Non-faculty specialist doctor
Latest degree
Subspecialist
Other areas of specialty/work
infants
Street address
Pakenjad Blvd., 12th St., Pone Alley, No 3
City
Yazd
Province
Yazd
Postal code
8916976535
Phone
+98 35 3728 1723
Email
drlookzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Marzieh Poorakremi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dadgostari Ave, 4th Alley
City
Abarkooh
Province
Yazd
Postal code
8931913497
Phone
+98 35 3282 9120
Email
mpoorakrami64@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