The comparison between the effect of two non-nutritive-sucking methods include emptied breast and pacifier sucking on the time needed to achieve full oral feeding in preterm infants
The aim of this study is to determine the effect of non-nutritive-sucking with two methods of emptied breast and pacifier sucking on the time needed to achieve full oral feeding in preterm infants. This study is a triple blind clinical trial with simple random sampling on 78 premature infants. New born infants with gestational age between 26 to 33 weeks and birth weight less than 1500 gr and physiological stability while starting oral stimulation will enter to study.
Having any congenital anomalies, chronic medical problems during or after oral stimulation program, seizure in the first 24 hours after birth, ability to natural sucking and oral feeding, infant will be excluded from the study.
Infants under study will be divided randomly into three groups included: two intervention groups and one control group. Oral stimulation program will be performed using a pacifier twice a day in the first group, and using mothers' breast twice a day in the second group, for ten days consecutively.
The control group in addition to receive routine nursing care infants will be received non-specialized head and face stimulates as placebo.
The participants will be assessed for time to achieve full oral feed, the weight gain after a week and after 10 days of oral stimulation program and the weight gain at discharge, gestational age at the time of oral feeding and discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122325673N1
Registration date:2016-09-26, 1395/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-26, 1395/07/05
Registrant information
Name
zahra Mahdavi
Name of organization / entity
Isfahan university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 5254 3374
Email address
z_mahdavi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Dezful University of Medical Sciences
Expected recruitment start date
2016-07-30, 1395/05/09
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effect of two non-nutritive-sucking methods include emptied breast and pacifier sucking on the time needed to achieve full oral feeding in preterm infants
Public title
Comparison between two non-nutritive-sucking methods on the time needed to achieve full oral feeding in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: newborn infant; birth gestational age between 26 to 33 weeks; birth weight < 1500 gr; physiological stability while starting oral stimulation, which means that oral stimulation and start feeding do not make change in the autonomic nervous system (skin color, heart rate and respiratory rate).
Exclusion criteria: Congenital anomalies; chronic medical problems include bronchopulmonay dysplasia, intraventricular hemorrhage (grade 3 and 4), enterocolitis necrosis and nosocomial Infection during or after oral stimulation program; having seizure in the first 24 hours after birth; being able to natural sucking and oral feeding.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dezful University of Medical Sciences
Street address
Dezful University of Medical Sciences, Azadegan Blv.
City
Dezful
Postal code
00986142429532
Approval date
2015-07-29, 1394/05/07
Ethics committee reference number
IR.DUMS.RES.1394.6
Health conditions studied
1
Description of health condition studied
Preterm neonate's nutritinal status
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Time needed to achieve full oral feeding
Timepoint
Seven and ten days after onset of intervention and at the time of discharge
Method of measurement
Counting the number of feedings per day
Secondary outcomes
1
Description
Weight
Timepoint
Seven and ten days after onset of intervention and at the time of discharge
Method of measurement
Model DG-110 Digital Scale
2
Description
Gestational age
Timepoint
At the time of discharge
Method of measurement
Gestational age at birthday plus the number hospitalization
3
Description
Hospitalization period
Timepoint
At the time of discharge
Method of measurement
Number of hospitalization days
Intervention groups
1
Description
In the first intervention group, non-nutritional sucking stimulation will be performed using a pacifier twice a day in the morning and in the evening while doctor start to feed infant. The intervention will be performed for 10 consecutive days by trained expert. Oral stimulation program contains two forms of oral stimulation. Around and in mouth stimulation will be done by hand for three minutes and it will be continued sucking by use of a pacifier for two minutes.
Category
Rehabilitation
2
Description
In the second intervention group, non-nutritional stimulation will be done by use of breast twice a day in the morning and in the evening for 10 consecutive days by trained experts. Before stimulation, breast milk will be fully discharged. Also before stimulation hands will be washed with soap and water and latex gloves will be used. Oral stimulation program contains two forms of oral stimulation. Around and in mouth stimulation will be done by hand for three minutes and it will be continue by sucking breast for two minutes. Before, during and after the stimulation, the infant will be monitored by the investigator and stimulation will stop immediately observing any interruption in breathing, slow heart rate and disruption in the oxygen supply.
Category
Rehabilitation
3
Description
In the control group, infants will receive non-specialized head and face stimulation in addition to routine nursing care, as placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ganjavian Hospital of Dezful
Full name of responsible person
Narges Majidipour
Street address
Opposite of Type 292 Zerehy Dezful, Road of Dezful-Andimeshk, Dezful
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Fereidon Nirouzad
Street address
Vice chancellor of Research, Dezful University of Medical Sciences, Azadegan Blv.
City
Dezful
Grant name
1245022
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezful University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Narges Majidipour
Position
Master of Nursing Neonatal Intensive Care/Memeber of faculty in Dezful University of Medical Science
Other areas of specialty/work
Street address
Dezful University of Medical Sciences, Azadegan Blv, Dezful, khuzestan, Iran.
City
Dezful
Postal code
6461895916
Phone
+98 61 4242 9532
Fax
+98 61 4242 9041
Email
info@Dums.ac.ir
Web page address
www.dums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Narges Majidipour
Position
Master of Nursing Neonatal Intensive Care
Other areas of specialty/work
Street address
Dezful University of Medical Sciences, Azadegan Blv, Dezful, Khuzestan, Iran.
City
Dezful
Postal code
6461895916
Phone
+98 61 4242 9532
Fax
+98 61 4242 9041
Email
info@Duma.ac.ir
Web page address
www.dums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Narges Majidipour
Position
Master of Nursing Neonatal Intensive Care
Other areas of specialty/work
Street address
Dezful University of Medical Science, Azadegan Blv
City
Dezful
Postal code
6461895916
Phone
+98 61 4242 9532
Fax
+98 61 4242 9041
Email
info@Dums.ac.ir
Web page address
www.dums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)