Comparison of the effect of cup, syringe and finger feeding on timing of complete oral feeding and weight gain in preterm infants: a randomized controlled clinical trial
Comparison of the effect of cup, syringe and finger feeding on timing of complete oral feeding and weight gain in preterm infants
Design
Clinical trial has three intervention groups, with parallel, no blind, randomized, phase 2 groups on 99 patients. Excel software rand function was used for randomization.
Settings and conduct
The target population is premature infants 30-30 weeks hospitalized in the intensive care unit of Al-Zahra and Taleghani educational and medical centers in Tabriz. The total sample size will be 99 people and the sample size in each group will be 33 people.
Participants/Inclusion and exclusion criteria
The age of the infant at the time of sampling is 30-34 weeks with stable clinical condition
Ability to swallow of newborn for two days
Apgar fifth minute at birth higher than 7
Intervention groups
En Intervention group 1:The baby is kept in a sitting or semi-sitting position with head-body coordination.The edge of the cup is placed on the lower lip of the baby and the baby sucks the milk from the cup with forward movements of the tongue.
En Intervention group 2: After washing the hands and wearing disposable gloves, the researcher or mother will glue the stomach tube to her little finger. By placing a finger in the baby's mouth and sucking, the milk will be transferred to the baby's mouth through the stomach tube.
Intervention group 3: In this feeding method, the piston is squeezed while the premature baby is sucking and the milk is directed to the inside of the cheek.
Main outcome variables
Time to achieve complete oral nutrition; weight gain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150424021917N11
Registration date:2020-12-22, 1399/10/02
Registration timing:registered_while_recruiting
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cup, syringe and finger feeding on timing of complete oral feeding and weight gain in preterm infants: a randomized controlled clinical trial
Public title
Effect of cup, syringe and finger feeding on timing of complete oral feeding and weight gain in preterm infants: a randomized controlled clinical trial
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the infant at the time of sampling is 30-34 weeks with stable clinical condition
Ability to swallow of newborn for two days
Apgar minute 5 higher than 7
Exclusion criteria:
Intra Ventricular Hemorrhage grade 3 or 4
Sepsis
Newborn under CPAP or ventilator
Congenital malformation
Down Syndrome
Neuromuscular diseases
Age
From 210 days old to 238 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to three groups of finger feeding, cup feeding, and syringe feeding blocks with blockes size 6 and 9 ratio of 1: 1. The allocation sequence will be determined using Random Allocation Software (RAS). To allocation cocealment, the type of intervention will be written on paper and placed in sealed opaque envelopes that are numbered sequentially. The envelopes will be opened by the person not involved in the sampling.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.TBZMED.REC.1399.819
Health conditions studied
1
Description of health condition studied
Premature neonate
ICD-10 code
P07.33
ICD-10 code description
premature neonate, gestational age 30 completed weeks
Primary outcomes
1
Description
Time to reach complete oral nutrition
Timepoint
Before the intervention and then after the intervention
Method of measurement
Using a researcher-made questionnaire
Secondary outcomes
1
Description
The rate of weight change
Timepoint
The baby's weight will be measured at the beginning of the study and then daily at a specific time in the morning shift before feeding and then after feeding the baby daily until full oral feeding.
Method of measurement
Weight in grams with a digital scale
Intervention groups
1
Description
Intervention group 1: 33 premature infants will be breastfed or complementary milk with a 50 ml disposable plastic cup.The baby is kept in a sitting or semi-sitting position with head-body coordination.The edge of the cup is placed on the lower lip of the baby and the baby sucks the milk from the cup with forward movements of the tongue.
Category
Other
2
Description
Intervention group 2: 33 premature infants will be fed with breast milk or complementary milk through a gavage tube attached to the mother's finger.In this method, breast milk or auxiliary milk is poured into a syringe and a gastric tube is attached to it. After washing the hands and wearing disposable gloves, the researcher or mother will glue the stomach tube to her little finger. By placing a finger in the baby's mouth and sucking, the milk will be transferred to the baby's mouth through the stomach tube.
Category
Other
3
Description
Intervention group 3: 33 premature infants will be fed breast milk or complementary milk through a syringe.In this feeding method, the piston is squeezed while the premature baby is sucking and the milk is directed to the inside of the cheek.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Sevil Hakimi
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
6579351386
Phone
+98 41 3553 9161
Email
Pr.alinezhad@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani Educational and Medical Center, Tabriz
Full name of responsible person
Sevil Hakimi
Street address
Taleghani Hospital,Rahahan,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4423
Email
Pr.alinezhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
Pr.alinezhad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology 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
Tabriz University of Medical Sciences
Full name of responsible person
Parinaz Alinazhad Shebilouy Sofla
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery, Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 912 603 5672
Email
Pr.alinezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0414796770
Email
hakimis@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 912 603 5672
Email
hakimis@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared. The results of the clinical study will be published as an article.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to the article
From where data/document is obtainable
sevil hakimi - hakimis@tbzmed.ac.ir
What processes are involved for a request to access data/document
The applicant notifies the applicant by email, after receiving the email the results are sent.