Determining the comparison of two methods of finger and cup feeding on weight gain and achieving independent oral feeding in premature infants admitted to the intensive care unit
Design
A control trial with a control group with Parallel groups, one-way blind, randomized, on 90 patients, was used for limited type randomization under the title "Random Allocation Rule".
Settings and conduct
The study was performed on premature infants in the intensive care unit of Ali Ibn Abi Talib Hospital in Zahedan. By positioning the baby, we feed the baby and the baby doctor will not be aware of the assignment of the subjects.
Participants/Inclusion and exclusion criteria
Entry requirements:
- Stable clinical condition (approved by the neonatologist)
- Gestational age from 30 to 35 weeks
- Have received full tube feeding
No entry requirements :
- Infants with a history of underlying diseases
- Infants taking sedatives
- Infants with genetic syndromes and congenital anomalies of the head and neck
Intervention groups
In the intervention groups, by positioning the infant, the infant begins to be fed by finger or cup method, and the control group receives its routine feeding through gavage.
Main outcome variables
weight gain؛ Achieve independent oral nutrition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220302054171N1
Registration date:2022-05-09, 1401/02/19
Registration timing:prospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Fatemeh Mirzaei badizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3244 4820
Email address
fa.mirzaei.997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-04, 1401/03/14
Expected recruitment end date
2023-03-05, 1401/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of two methods of finger feeding and cup feeding on the weight gain and achieve to independent oral nutrition premature infants
Public title
Comparison of the effectiveness feeding methods in premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Stable clinical condition
Gestational age from 30 to 35 weeks
Receive OGT feeding completely
Exclusion criteria:
Infants with a history of underlying diseases
Infants with sedative Receive
Infants with neurological diseases and congenital head and neck abnormalities
Infants with genetic syndromes
Infants with underlying diseases
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be placed in intervention and control groups by the limited randomization method called "Random allocation rule"; In this way, 90 color cards identifying the study groups (red card of intervention 1, blue card of intervention 2 and white card of control group) will be prepared for the total number of patients studied and the patient will be selected based on the color cards. Eligible will be placed in groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that only the diagnosis and decision about starting oral feeding and the number of times of oral feeding per day is made by the neonatologist present in the ward, so they will not be aware of the allocation of subjects in the two intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Zahedan University of Medical Sciences
Street address
Main campus of medical sciences, Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.ZAUMS.REC.1401.029
Health conditions studied
1
Description of health condition studied
Weight gain and achievement of independent oral nutrition in premature infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weigh gain of premature infants through the Beurer calibrated scale in the neonatal intensive care unit
Timepoint
Weight measurement at the beginning of the intervention and 72 hours after feeding
Method of measurement
Beurer calibrated scales
2
Description
Achieve to independent oral nutrition
Timepoint
Assessing the frequency of achieving oral independence 72 hours after the start of the nutritional intervention
Method of measurement
Breastfeeding
Secondary outcomes
1
Description
Adequacy of nutrition
Timepoint
Before the intervention and 72 hours after the intervention
Method of measurement
Calibrated cup of Espadana company
Intervention groups
1
Description
First Intervention group: The meaning of cup feeding is that breast milk is prepared in a graduated plastic cup from Espadana company. While sitting, hold the baby slightly backwards, hold the cup of milk in front of the baby's lips, and gently place it on the baby's lower lip in the gap between the lower lip and gums. Then tilt the cup so that the milk reaches the baby's lips. The premature baby eats the milk from the cup with forward movements of the tongue.
Category
N/A
2
Description
Second Intervention group: For finger feeding, this is how it is done: Tube number five is used, which is fixed with a thin adhesive tape on the little finger of the researcher, one end of which is attached to the finger and the other end to the 5 cc of Laurel Ava syringe. Hold the baby upright and gently pour the milk into the baby's mouth each time, with the milk between the gums and cheeks or on the baby's tongue. The baby is then allowed to swallow the milk.
Category
N/A
3
Description
Control group: Receive routine ward care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib hospital
Full name of responsible person
Fatemeh Mirzaei Badizi
Street address
In front of Imam Khomeini Mosque, Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
fa.mirzaei.997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Campus of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
fa.mirzaei.997@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahin Naderifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Campus of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
fa.mirzaei.997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahin Naderifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Campus of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
fa.mirzaei.997@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahin Naderifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Campus of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
fa.mirzaei.997@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