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Investigating The Effect of Colostrum Therapy in Preterm Infant with Birth Weight less than 1800g at Neonatal Intensive Care Unit

Protocol summary

Study aim
Investigating The Effect of Colostrum Therapy in Preterm Infant with Birth Weight less than 1800g in Neonatal Intensive Care Unit
Design
A randomized controlled clinical trial with a control group, not blinded ,no placebo which is conducted on 104 premature infants. The samples (into two groups) will be assigned to two groups by permuted block randomization.
Settings and conduct
Neonatal Intensive Care Unit of Al-Hadi Shushtar Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria : Gestational age less than 33 weeks, Birth weight less than 1800 grams, Hospitalization in the NICU of Al-Hadi Hospital within the first 24 hours of birth, Ability to start intervention up to 72 hours after birth Exclusion criteria : birth anomalies, Severe asphyxia (Apgar score less than 3 in the first minute, arterial pH less than 7.0), Presence of fatal diseases (severe Intraventricular hemorrhage (IVH) , metabolic problems, etc.), Diagnosis of tracheoesophageal fistula, Chromosomal syndromes
Intervention groups
Pre-prepared colostrum in an insulin syringe (0.1-0.2ml according to the age and weight of the baby) will be injected into the baby's buccal cavity by the little finger of the researcher and massages with the Cheek C stretch technique for 10 seconds. In the control group, no intervention was performed in addition to the routine care of the neonatal intensive care unit
Main outcome variables
Evaluating the effect of colostrum therapy on The need to PIOMI (premature infant oral motor intervention), The Incidence of Necrotizing Enterocolitis, Duration of hospitalization, Time to achieve full enteral nutrition, milk tolerance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240501061616N1
Registration date: 2024-07-30, 1403/05/09
Registration timing: prospective

Last update: 2024-07-30, 1403/05/09
Update count: 0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Niayesh Tahmasebi nezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3621 0399
Email address
nsh.tahmasebi@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2025-06-10, 1404/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect of Colostrum Therapy in Preterm Infant with Birth Weight less than 1800g at Neonatal Intensive Care Unit
Public title
Investigating The Effect of Colostrum Therapy in Preterm Infant with Birth Weight less than 1800g at Neonatal Intensive Care Unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational Age less than 33 weeks Birth Weight less than 1800 grams Hospitalization in the Neonatal Intensive Care Unit of Al-Hadi Hospital within the first 24 hours of birth Ability to start intervention up to 72 hours after birth
Exclusion criteria:
Birth Anomalies Severe Asphyxia (Apgar score less than 3 in the first minute, Arterial pH less than 7.0) Presence of Fatal Diseases (severe Intraventricular Hemorrhage (IVH), Metabolic Problems, etc.) Diagnosis of Tracheoesophageal Fistula Chromosomal Syndromes
Age
From 1 day old to 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committees of Shoushtar Faculty of Medical Sciences
Street address
Al-Hadi Hospital, West Shahid Rajaie Cross, Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
IR.SHOUSHTAR.REC.1403.008

Health conditions studied

1

Description of health condition studied
Prematurity birth
ICD-10 code
P07.30
ICD-10 code description
Preterm newborn, unspecified weeks of gestation

Primary outcomes

1

Description
Milk Tolerance
Timepoint
During hospitalization
Method of measurement
Counting the days

Secondary outcomes

1

Description
The need to PIOMI (premature infant oral motor intervention)
Timepoint
During hospitalization
Method of measurement
Counting cases

2

Description
The Incidence of Necrotizing Enterocolitis
Timepoint
During hospitalization
Method of measurement
Clinical assessment

3

Description
Duration of hospitalization
Timepoint
End of hospitalization
Method of measurement
Counting the days

4

Description
The amount and concentration of oropharyngeal and nasopharyngeal secretions
Timepoint
During hospitalization
Method of measurement
Clinical assessment

5

Description
Time to achieve full enteral nutrition
Timepoint
During hospitalization
Method of measurement
Counting the days

Intervention groups

1

Description
Intervention group: After the birth of the baby, mothers first, learn how to express their milk and store colostrum, then they are asked to express their milk as soon as possible (6-8 hours after birth). The researcher will wears sterile gloves and Pre-prepared colostrum in an insulin syringe (0.1-0.2ml according to the age and weight of the baby) will be injected into the baby's buccal cavity by the little finger of the researcher and massages with the Cheek C stretch technique for 10 seconds (on each side)(Cheek C stretch technique is one step of premature infant oral motor intervention(PIOMI)). The intervention is repeated every 6-8 hours up to 5 days.
Category
Treatment - Other

2

Description
Control group: The control group will be received all routine care in the Neonatal Intensive Care Unit. And this group will be without placebo.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Hadi hospital
Full name of responsible person
Niayesh Tahmasebi nezhad
Street address
Al-Hadi hospital, West Shahid Rajaie Cross, Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516-84534
Phone
+98 61 3621 0399
Fax
Email
nsh.tahmasebi@gmail.com
Web page address
https://hs-alhadi.shoushtarums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Marzie Ahmadian
Street address
West Shahid Rajaie Cross, Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516-84534
Phone
+98 61 3621 0399
Email
AHMADIAN.T19@GMAIL.COM
Web page address
https://behsan.shoushtarums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shooshtar 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
Shooshtar University of Medical Sciences
Full name of responsible person
Niayesh Tahmasebi nezhad
Position
Nurse Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
NICU, Al-Hadi hospital, West Shahid Rajaie Cross, Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516-84534
Phone
+98 61 3621 0399
Fax
Email
nsh.tahmasebi@gmail.com
Web page address
https://hs-alhadi.shoushtarums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Ali Khosravi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Al-Hadi hospital, West Shahid Rajaie Cross, Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516-84534
Phone
+98 61 3621 0399
Fax
Email
Khosraviali071@gmail.com
Web page address
https://hs-alhadi.shoushtarums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Niayesh Tahmasebi nezhad
Position
Nurse Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Neonatology
Street address
NICU, Al-Hadi hospital, West Shahid Rajaie Cross, Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516-84534
Phone
+98 61 3621 0399
Fax
Email
nsh.tahmasebi@gmail.com
Web page address
https://hs-alhadi.shoushtarums.ac.ir

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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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