Comparison of the efficacy of combination ( oral sensory-motor stimulation, nonnutritive sucking and oral support ) versus nonnutritive sucking on feeding performance in premature infants
To determine the effect of oral sensory-motor stimulation, non-nutritive sucking and oral support compared to non-nutritive sucking on feeding performance of premature infants.
Design
In this study, 44 preterm and premature infants who are referred to hospitals affiliated to Iran University of Medical Sciences are selected. Participants are randomly divided into intervention and control groups.
Settings and conduct
Premature infants admitted to the neonatal intensive care unit are treated in two different intervention groups for 14 consecutive days.
This research has 7 stages of evaluation: before treatment, seventh day, fourteenth day, seventeenth day, twentieth day, twenty third day, final evaluation stage: The day that the infant has reached independent oral feeding. The assessment is performed using the "Preterm infant Oral Feeding Readiness Assessment Scale".
Both treatment methods are performed by the investigator and all stages of the assessment by an individual other than the investigator who is blind to the treatments provided.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: modified fetal age of less than 36 weeks; no disability of oral feeding.
Exclusion criteria: respiratory, cardiovascular, digestive and neurological problems or congenital syndromes.
Intervention groups
In the combined treatment group, newborns are stimulated by sensory motor stimulation for 12 minutes and 3 minutes of non-nutritive sucking with a pacifier, and receive oral milk with a glass of milk twice a day. Infants in the non-nutritive group are stimulated with a pacifier for about 5 minutes at 7-8 times.
Main outcome variables
Score of Preterm infant Oral Feeding Readiness Assessment Scale; Infant weighting; Volume of milk intake per day; Duration of full oral feeding; Duration of hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171023036956N2
Registration date:2018-04-23, 1397/02/03
Registration timing:prospective
Last update:2018-04-23, 1397/02/03
Update count:0
Registration date
2018-04-23, 1397/02/03
Registrant information
Name
Alireza Alidad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4438 3685
Email address
alidad.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Iran University of Medical Sciences
Expected recruitment start date
2018-04-25, 1397/02/05
Expected recruitment end date
2018-06-26, 1397/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of combination ( oral sensory-motor stimulation, nonnutritive sucking and oral support ) versus nonnutritive sucking on feeding performance in premature infants
Public title
The effect of combination therapy on feeding performance in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
An infant with a corrected gestational age of less than 36 weeks
The infant's weight is proportionate to the gestational age
Apgar score equal to or greater than 3 in 1 minute and equal to or greater than 5 in 5 minutes
The infant does not have the ability for oral feeding
Exclusion criteria:
Family unwillingness to continue treatment
The infant has facial abnormalities
The infant has respiratory, cardiovascular, digestive and neurological problems or congenital syndromes
Infants with chronic medical conditions during NICU hospitalization, such as intraventricular hemorrhage and pulmonary dysplasia
Age
To 6 months old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Each premature infant with inclusion criteria will be introduced into the study group by simple random sampling. In the second step, allocation of samples will be done by random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, both therapy methods are performed by the researcher and all stages of the assessment by an individual other than the researcher, who is blind to the intervention process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411360007
Health conditions studied
1
Description of health condition studied
difficulties in oral feeding of premature infants
ICD-10 code
R63.3
ICD-10 code description
Feeding difficulties
Primary outcomes
1
Description
score of Preterm Infant Oral Feeding Readiness Assessment Scale
Timepoint
The first stage: Before the treatment, the second stage: the seventh day, the third stage: the day of the fourteenth, the fourth stage: the seventeenth day, the fifth stage: the twentieth day, the sixth stage: the twenty-third day, the final assessment stage: the day the infant is given an independent oral feeding.
Method of measurement
Preterm Infant Oral Feeding Readiness Assessment Scale(Score between 0 and 36)
Secondary outcomes
1
Description
infant weight
Timepoint
The first stage: Before the treatment, the second stage: the seventh day, the third stage: the day of the fourteenth, the fourth stage: the seventeenth day, the fifth stage: the twentieth day, the sixth stage: the twenty-third day, the final assessment stage: the day the infant is given an independent oral feeding.
Method of measurement
Scales (gr)
2
Description
The amount of milk received
Timepoint
Daily
Method of measurement
Syringe (ml)
3
Description
Duration of full oral feeding
Timepoint
The first stage: Before the treatment, the second stage: the seventh day, the third stage: the day of the fourteenth, the fourth stage: the seventeenth day, the fifth stage: the twentieth day, the sixth stage: the twenty-third day, the final assessment stage: the day the infant is given an independent oral feeding.
Method of measurement
Number of days
4
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Number of days
Intervention groups
1
Description
Intervention Group (Combinational therapy) : Infants in the combined treatment group are stimulated oral sensory stimuli for 12 minutes and 3 minutes with a pacifier, and are stimulated twice a day with an oral support technique .
Category
Rehabilitation
2
Description
Control Group (Non-nutritive sucking) : Infants in the non-nutritive sucking group are stimulated with a pacifier 7-8 times a day for 5 minutes.