The investigation effectiveness of cue-based feeding in Comparison with the traditional approach in preterm infant in neonatal intensive care unit
Design
Preterm infants will be entered into the study group by blocked random sampling. The block sampling method is to first create 4 blocks in each block of each group in equal numbers and then will be select a block from the blocks.
Settings and conduct
Participants will be recruited from the population of preterm infants in the neonatal intensive care unit at Dr Shariati hospital in Tehran born 34 week and less than 34 weeks’ gestational age.
Participants/Inclusion and exclusion criteria
Preterm infants 34 week and less than 34 weeks’ gestational age at birth, Infant don’t able to oral feeding, Infants that don’t have neurological disorders, gastrointestinal disorders, or major congenital anomalies and Apgar score 3 or more in first one minutes and 5 or more in the five minutes will be
Intervention groups
cue-based feeding when they show cue be feeding
Main outcome variables
infant’s specifications such as gestational age, sex, Weight gain (grams per day, or grams per
kilogram per day), duration of hospital admission: Postmenstrual age (days from birth) to discharge to home from hospital. Age (postmenstrual age and days from birth) at establishment of full oral feeding (independent of intragastric
tube feeding), age of oral feeding start and duration of full oral feeding will be recorded in a demographic questionnaire at the baseline assessment. All outcome measures will be measured by the researcher at baseline, start of oral feeding, full oral feeding and the final treatment session (discarge), and at a follow-up measurement after 2 weeks
Readiness assessment Scale(POFRSS):
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20180611040062N1
Registration date:2018-10-17, 1397/07/25
Registration timing:registered_while_recruiting
Last update:2018-10-17, 1397/07/25
Update count:0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Farideh Kamran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7763 6042
Email address
f-kamran@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-09-22, 1397/06/31
Actual recruitment end date
2019-05-22, 1398/03/01
Trial completion date
2019-06-23, 1398/04/02
Scientific title
The investigation effectiveness of cue-based feeding in Comparison with the traditional approach in preterm infant in neonatal intensive care unit
Public title
The investigation effectiveness of cue-based feeding in Comparison with the traditional approach in preterm infant in neonatal intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm infants 34 week and less than 34 weeks’ gestational age at birth
and Apgar score 3 or more in first one minutes and 5 or more in the five minutes
Infants that don’t have neurological disorders, gastrointestinal disorders, or major congenital anomalies
respiratory, cardio conditions be stable
Infant don’t able to oral feeding
Exclusion criteria:
Family’ loss of interest to continue in the study
Unstable condition of the infant
Remove the infant from the study in case of weight loss and increase the severity of the infant's problem
Age
From 182 days old to 238 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
infant is particpant who dont have aware
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran university of medical science
Street address
enqelab Ave,shemron, school of rehabilitation
City
Tehran
Province
Tehran
Postal code
1563663313
Approval date
2018-06-21, 1397/03/31
Ethics committee reference number
IR.TUMS.FNM.REC.1397.010
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
age of oral feeding start
Timepoint
during intervention
Method of measurement
number of day
2
Description
duration of full oral feeding
Timepoint
after intervention (discharge)
Method of measurement
number of day
Secondary outcomes
1
Description
Weight
Timepoint
before intervention
Method of measurement
balance
2
Description
The assessment of the infant’s oral feeding readiness
Timepoint
before intervention/start oral feeding day/ full oral feeding day/ discharge day
Method of measurement
Readiness assessment Scale
3
Description
Early feeding skills
Timepoint
start oral feeding day/ full oral feeding day/ discharge day
Method of measurement
Early feeding skill scale
4
Description
duration of hospital admission
Timepoint
after intervention( discharge day)
Method of measurement
day
Intervention groups
1
Description
Intervention group: Initially, infants will be evaluated 15 minutes before feeding by the oral feeding readiness assessment scale. If infant receive a score of more than 30, they will be prepared for oral feeding and, also will be begin oral feeding by a neonatal specialist diagnosis, and will use a Early feeding skill scale to get a profile of the infant's early feeding skills.When neonates reached 32 PMA no longer received mechanical ventilation, and tolerated full enteral feedings, physicians ordered assessment of the infants’ readiness for oral feedings during each scheduled care time, typically every 3 hours. At morning to afternoon, speech-language pathology reviewed infants’ scores on the Oral Feeding Readiness Scale. When infants achieved scores of 4 or 5 at 50% or more of their feeding times, health care providers ordered to begin cue-based oral feedings Infants were offered oral feedings each time their readiness scores were 4 or 5. Speech-language pathology continuously evaluated the quality of oral feedings for preterm infants on the Oral Feeding Quality Scale. An oral feeding was discontinued if the infant demonstrated two disengagement or distress cues (e.g., behaviors scored as 0 or 1 on the scale, such as falls asleep,nasal flaring, arching, or an uncoordinated suck– swallow–breathe pattern that resulted in bradycardia or oxygen desaturation). Each oral feeding could last up to 30 minutes, at which time the remaining milk was gavage fed. Infants continued on the cue-based feeding protocol until they were able to take their prescribed volume orally at each feeding.However, if the infant receives less than 30 scores in the assessment of oral feeding readiness, it is not ready for oral feeding. According to oral infant's skills, interventions such as oral non-nutritional sucking, skin to skin contact will be do before feeding with the tube at the time when the infant reaches to oral feeding.
Category
Rehabilitation
2
Description
Control group: Initially, infants will be evaluated 15 minutes before feeding by the oral feeding readiness assessment scale. If infant receive a score of more than 30, they will be prepared for oral feeding and, also will be begin oral feeding by a neonatal specialist diagnosis, and will use a Early feeding skill scale to get a profile of the infant's early feeding skills thanFeedings are begun on a timed or scheduled basis without regard to infant status. Infants are awakened from sleep to feed. Successful feeding is measured by volume intake, regardless of infant behaviors
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
shariati hospital
Full name of responsible person
farideh kamran
Street address
north kargar Ave, shariat hospital
City
tehran
Province
Tehran
Postal code
0098 9177622352
Phone
+98 21 7763 6042
Email
f-kamra@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr shadmehr
Street address
دانشکده توانبخشی، پیچ شمرون ، خیابان انقلاب
City
Tehran
Province
Tehran
Postal code
1563663313
Phone
+98 21 7753 3939
Email
f-kamran@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
farideh kamran
Position
master
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
دانشکده توانبخشی
City
Tehran
Province
Tehran
Postal code
1563663313
Phone
+98 21 8670 5503
Email
f-kamran@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
farideh kamran
Position
master
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
دانشکده توانبخشی
City
tehran
Province
Tehran
Postal code
1563663313
Phone
+98 21 7768 4941
Email
f-kamran@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
farideh kamran
Position
master
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
دانشکده توانبخشی
City
tehran
Province
Tehran
Postal code
1563663313
Phone
+98 21 7768 4941
Email
f-kamran@razi.tums.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
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