Assessment of the effect of integrated mother's milk odor and Nonnutritive Sucking on the time of achievement independent oral feeding in preterm neonates
The aim of this study is evaluation of the effect of Integrated Mother's Milk Odor with Nonnutritive Sucking (NNS) on the time of achievement of the independent oral feeding in preterm infants (34 infants; 17 in intervention and 17 in control group). The study will be accomplished in the trail phase two with simple randomization. Blinding will be applied with mothers of the infants (single blind) and they will not be aware of the method. The 28-32 gestational weeks newborns who will hospitalize in Tehran Mahdiye and Shohadaye Tajrish hospital will be recruited in this study. Eligibility criteria consistence of Apgar score more than 6 in fifth minute after birth, minimum weight 1000 gr at birth and the ability of gavage tolerance. Newborns with any kind of congenital abnormalities or disease and sepsis will be excluded. Both groups will receive NNS, intervention group will receive the odor stimulation via cotton soaked in their mother’s milk, at first 5 minute of gavage feeding ,three times daily during 10 continuously days; control group will receive NNS and a piece of dry cotton. Primary outcome will be to decrease the time of achievement of independent oral feeding, and secondary outcomes will be to increase the average of weight gain, to decrease the hospitalization in intervention group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082829574N1
Registration date:2017-01-03, 1395/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Zahra Khodagholi
Name of organization / entity
University of social welfar and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 4208
Email address
za.khodagholi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Myself
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of integrated mother's milk odor and Nonnutritive Sucking on the time of achievement independent oral feeding in preterm neonates
Public title
The effect of mother milk odor and nonnutritive sucking on independent feeding
Purpose
Treatment
Inclusion/Exclusion criteria
Eligibility criteria:
The gestational age between 28 and 32 weeks and 6 days at birth; Being Started gavage feeding and tolerated it by the infant; The minimum birth weight 1000 gram; The physiological stability (heart rate, blood pressure, respiratory rate and oxygen saturation according to age) during the 24 hours before intervention; The Apgar score more than 6 at fifth minute after birth; The signed consent form by parents.
Exclusion criteria:
Newborn with congenital malformations; chromosomal abnormalities; intraventricular hemorrhage grade 3 and 4; necrotizing enterocolitis; asphyxia and neonatal seizures; neonatal jaundice leading to blood transfusions and positive sepsis work up; transfer to another hospital
Age
From 3 days old to 12 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Univesity of Social Welfare and Rehabilitation
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Approval date
2016-10-03, 1395/07/12
Ethics committee reference number
IR.USWR.REC.1395.210
Health conditions studied
1
Description of health condition studied
To achieve independent oral feeding in preterm infants
ICD-10 code
p92.2, p92
ICD-10 code description
Slow feeding of newborn; Neonatal difficulty in feeding at breast; Feeding problem of newborn, unspecified
Primary outcomes
1
Description
Time to achieve 8 time independent oral feeding
Timepoint
During and after intervention until the 8 times independent feeding
Method of measurement
Nursery report of independent feeding via breast milk or bottle feeding
Secondary outcomes
1
Description
echological age discharge time
Timepoint
before the intervention, birthday until discharge time
Method of measurement
The days after birth until discharge time
2
Description
Newborn's age according to last menstrual period (LMP) at discharge
Timepoint
At discharge time
Method of measurement
The days from last menstrual age (LMP) until the discharge day
3
Description
Average weight intake during two weeks after the intervention
Timepoint
Concurrently with intervention, daily during 2 weeks
Method of measurement
Seca baby electrical scale 354 produced by German company
Intervention groups
1
Description
Intervention Group1: In intervention group1 the odor stimulation will be used concurrently with Nonnutritive Sucking (NNS) in first 5 minutes of gavage feeding for 3 times consecutively during 10 days without stop. The odor stimulation include a piece of cotton soaked in daily mother's milk that is in body temperature. This cotton will be put 2-3 cm near the nose of the newborn. The NNS will be performed by using the gloved small finger that stroke the palate to stimulate sucking.
Category
Treatment - Other
2
Description
Group2 (Control): In control group only the NNS in first 5 minutes of gavage feeding for 3 times consecutively during 10 days without stop with a dry cotton will be used. The NNS will be performed by using the gloved small finger that stroke the palate to stimulate sucking.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Educational Hospital
Full name of responsible person
DR Maryam Khoshnud Shariyati
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq
City
Tehran
2
Recruitment center
Name of recruitment center
Shohada Tajrish Educational Hospital
Full name of responsible person
DR Maryam Khoshnud Shariyati
Street address
Tajrish Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Myself
Full name of responsible person
Zahra Khodagholi
Street address
Shohada Tajrish Educational Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?