Evaluation of the Premature Infant Oral Motor Intervention (PIOMI) on Oral Feeding Progression in Preterm Infants With Gestational Age between 26-29weeks.
Comparison of Weight at the time of reach one, four, eight and discharge of hospital; Gestational Age at the time of reach one, four, eight and discharge of hospital; feeding progression and length of hospital stay between control group and intervention group.
Design
Clinical trials with intervention and control group; parallel group design; Double blind, and randomized
Settings and conduct
This study is related to oral motor skills and oral nutrition of premature infants. We have collected data in Akbarabadi and Arash Hospital in Tehran.. The infants were randomly assigned into two intervention and control groups. The intervention group received 5 minutes of oral massage daily. The doctor determined the amount and manner of receiving milk and the time of discharge. The doctor was unaware of the grouping of babies
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants with gestational age(GA) between 26-29
Physiological stability at the onset of intervention
Parental consent
Exclusion criteria: Failure to get gavage before the end of the 29th week (GA)
chronic illness or genetic problems
Intervention groups
The intervention group received 5 minutes of oral massage per day for 10 days, according to Premature Infants Oral Motor Intervention (PIOMI)
The control group only receives hospital routine services.
Main outcome variables
Feeding progression; Duration of transmission from oral gavage to full oral feeding; discharge from the hospital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180410039260N1
Registration date:2018-07-06, 1397/04/15
Registration timing:retrospective
Last update:2018-07-06, 1397/04/15
Update count:0
Registration date
2018-07-06, 1397/04/15
Registrant information
Name
Hadise Ghomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7795 6924
Email address
Ha.ghomi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-08-01, 1396/05/10
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Evaluation of the Premature Infant Oral Motor Intervention (PIOMI) on Oral Feeding Progression in Preterm Infants With Gestational Age between 26-29weeks.
Public title
evaluation of PIOMI on oral feeding in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with gestational age between 26-29 weeks
Physiological stability at the onset of intervention
Apgar score higher than 6 in the fifth minute after birth
Parental consent
Exclusion criteria:
Chronic genetic and medical problems
Parental dissatisfaction
No received of nutrition through gavage until the end of the 29th week of GA
Age
From 182 days old to 203 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and using the https://www.randomizer.org site.
Blinding (investigator's opinion)
Double blinded
Blinding description
infants mothers and doctors
The doctor examines the oral and nutritional capacity.The doctor does not know about the grouping of infants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of university of social walfare and rehabilitation science
Street address
University of social walfare and rehabilitation science, Koodakyar Ave, Daneshju blv, Evin, Trlehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.USWR.REC.1396.85
Health conditions studied
1
Description of health condition studied
Feeding in Premature infants
ICD-10 code
P92
ICD-10 code description
Feeding problems of newborn
Primary outcomes
1
Description
Feeding progression was calculated from the day when oral feedings were initiated to the day when full oral feedings were attained. Fewer days indicated faster progression.
Timepoint
postmenstrual age(PMA) on the time of one, fore and full oral feeding
Method of measurement
PMA , days
2
Description
Length of hospital stay
Timepoint
Gestational age in birth time and discharge time (day)
Method of measurement
Day
Secondary outcomes
1
Description
Weight on the time of one, fore and full oral feeding and discharge
Timepoint
Time of one, fore and full oral feeding and discharge
Method of measurement
Digital Balance in grams
Intervention groups
1
Description
Intervention group:5 Minute massage in and around the mouth using a PIOMI protocol, once a day for ten days
Category
Rehabilitation
2
Description
Control group: Medical and nursing services provided in all hospitals. There is no speech therapy intervention in these two hospitals
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان اکبرآبادی
Full name of responsible person
Ali Mazoury
Street address
Akbarabadi Hospital, Raees Abdollahi Street, Molavi street