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Evaluating of Two Nutrition Methods Cup Feeding and Finger feeding on Weight Gain and Nutrition Tolerance in Preterm Infants hospitalized in neonatal intensive care unit

Protocol summary

Study aim
Determining and comparing the effect of two feeding methods with cup and finger on weight gain and feeding tolerance of premature infants
Design
this randomized clinical trial study was done on 90 eligible preterm infants in two experimental groups and control group .Lottery method was used for randomization
Settings and conduct
after obtaining permission from the university ethics committee, the samples selected according to the inclusion and exclusion criteria from NICU. After obtaining informed and written consent from the parents to participate in the study, the samples were randomly divided into three groups including a control group and two experimental groups 1 and 2. In the experimental group No. 1, the infants were fed with a cup, in the experimental group No. 2, the infants were fed with a finger, and in the control group, the infants were fed by routine ward method.In this study, the nurse in charge of data recording and data analysis specialist was unaware of the groups.
Participants/Inclusion and exclusion criteria
inclusion criteria including Infants with a gestational age of 32 to 36 weeks, inability to breastfeed exclusion criteria :Term and post-term infants, feeding in other ways before the study, infants with anomalies such as neural and heart and respiratory, congenital diseases of the head and neck, necrotizing enterocolitis,genetic syndromes, infants in need of resuscitation and mechanical ventilation, Apgar score less than 5 in the fifth minute , grade 3 and 4 intracranial hemorrhage, sepsis, respiratory disorders
Intervention groups
Three groups were : including one control group and two experimental groups .group No. 1 were fed with cups, in the experimental group No. 2 neonates were fed with finger and in the control group ( 3) the infants were fed by routine method.
Main outcome variables
Weight, feeding tolerance of premature infants

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100411003679N2
Registration date: 2021-01-30, 1399/11/11
Registration timing: retrospective

Last update: 2021-01-30, 1399/11/11
Update count: 0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
Khadijeh Dehghani
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences, Yazd,Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
dehghanish@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
2020-06-04, 1399/03/15
Actual recruitment end date
2020-10-21, 1399/07/30
Trial completion date
2020-10-21, 1399/07/30
Scientific title
Evaluating of Two Nutrition Methods Cup Feeding and Finger feeding on Weight Gain and Nutrition Tolerance in Preterm Infants hospitalized in neonatal intensive care unit
Public title
Evaluating of Two Nutrition Methods Cup Feeding and Finger feeding on Weight Gain and Nutrition Tolerance in Preterm Infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age 32-36 weeks inability to breast feeding
Exclusion criteria:
term and post term infants feeding in other ways before the study neonates with neural and cardiac and respiratory abnormalities, congenital diseases of the head and neck, necrotizing enterocolitis, genetic syndromes infants in need of resuscitation, Apgar score less than 5 in the 5 minute, infants in need of mechanical ventilation Grade 3 and 4 intracranial hemorrhage, sepsis, respiratory disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 87
Actual sample size reached: 83
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of samples,the lottery method was used .three identical envelopes were prepared and a number was placed in each envelope, with number 1 representing infants with cups, experimental group 2 representing infants with a finger, and in control group 3 infants fed by routine method, Then one of the nurses who was not aware of the contents of the envelope was asked to choose one of the envelopes and the group of infants is determined according to the number in the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The research assistant nurse was not aware of the group research to record information about nutrition and weight tolerance. Also, the data analysis expert was unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics.research.ac.ir
Street address
Bahonar Square, the central building of Yazd University of Medical Sciences
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.SSU.REC.1398.211

Health conditions studied

1

Description of health condition studied
weighning and feeding tolerance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Average weight of premature infants
Timepoint
The mean weight of premature infants in three groups was measured before the intervention and then daily at the beginning of the morning shift before feeding and after the intervention.
Method of measurement
The weight of uncoated infants was measured by a special weight scale for infants with zyklus med model and an accuracy factor of 5 grams by the researcher from trained personnel working in the department and recorded in a special form.

2

Description
Percentage of feeding tolerance of premature infants
Timepoint
Before the start of each feeding
Method of measurement
To evaluate the feeding tolerance of infants, before the start of each feeding, the remaining amount of milk was measured using a syringe attached to the gastric catheter by gastric lavage. If this rate was more than 30% of breastfed or any of the clinical symptoms such as distension, vomiting, blood in the stool and fecal remnants, the cause of intolerance to nutrition was considered and recorded in the registration form.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Infants was fed by cup 4 times a day for 7 days, each time for 15-20 minutes. In this group, the infants were kept securely in a blanket in a sitting or semi-sitting position, and the infant's body was placed level. The milk from the mother or from the human milk bank was placed in a small cup, usually 30 to 50 cc in size, with the edge of the cup tangential to the baby's lower lip. With the movements of the tongue, the baby began to suckle. Feeding was completed when the predetermined volume of milk was consumed. The rate of rejection of milk or wasted milk by weighing the gas placed under the chin by a digital scale with a sensitivity of one tenth of a gram, which differed from the weight of infants Weighed.
Category
N/A

2

Description
Intervention group: The finger feeding technique was performed in a manner similar to that described by Fuji Naga et al., 2016. First, the tip of the feeding tube was cut and fixed with adhesive tape into the little finger of the glove. The finger pad was then inserted upwards into the baby's mouth and in front of the roof of his mouth. As the baby began to suck his finger, he gently pressed the plunger onto the syringe and the milk was drawn into the baby's mouth. So, the baby was eager to suck and swallow milk.
Category
N/A

3

Description
Control group: In the control group, feeding was performed routinely. In the routine method, infants were fed by droppers. In the drip feeding, the baby's head and torso were placed at an angle of 35 to 45 degrees and the prescribed amount of milk was reduced from the volume of the gavage and given with the drip.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd, Neonatal Intensive Care Unit
Full name of responsible person
khadijeh dehghani
Street address
Ibn Sina St., Shahid Sadoughi Hospital, Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
medschool@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr masoud mirzaeii
Street address
Bahonar Boulevard, the central building of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
yazd.ircme@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
khadijeh dehghani
Position
nursing instructor,faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
info@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
khadijeh dehghani
Position
academic member,nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Safaieh, Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
dehghanish@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
khadijeh dehghani
Position
nursing instructor ,faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
dehghanish@ssu.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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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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