Protocol summary

Summary
The aim of this study comparison the effect of non nutritive sucking and abdomen massage on feeding tolerance and weight changes in premature Infants. Inclusion criteria included: chronological age infants 48 hours or less, gestational age infants 30 to 34 weeks, receiving nutrition through a tube, fifth minute Apgar score of 7 and more, lack of sever respiratory distress, no need to mechanical ventilation, birth weight 1200 grams and more, absence of congenital disease. Exclusion criteria included the following: firms that have grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, positive blood culture at birth, sepsis were excluded from the sample. Population is all premature infants with gestational age 34-30 weeks and in Imam Reza hospital neonatal intensive care unit at Mashhad in 1394 admitted. The sample size based on previous studies and Average Comparison Formula 60 were considered. During the study, of which 8 samples of the study were excluded, and finally 52 infant completed the study. Infants were randomly assigned to three groups: abdominal massage, non-nutritive sucking and control. In abdominal massage group, intervention for 15 minutes twice a day, in non-nutritive sucking group intervention was performed for 10 minutes three times a day. Apart from routine services nursing infants in the control group did not receive any intervention. Intervention began in 48 hours of birth and continued for 7 days.Changes weight and feeding tolerance using three criteria: the amount of residue, vomiting and distention examined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110330672N1
Registration date: 2016-11-29, 1395/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
Saideh Marzieh Fazli
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1513
Email address
m-fazli@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Non Nutritive Sucking and Abdomen Massage on Feeding Tolerance and Weight Changes in premature born Infants
Public title
The impact of abdominal massage and nonnutritive sucking on feeding tolerance and weight in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria (48 hours or less chronological age baby; the baby's gestational age 30 to 34 weeks; Infant feeding via a nasogastric tube be done; fifth minute Apgar score of 7 and more; The absence of severe respiratory distress; lack of need for mechanical ventilation; lack of mother's addiction; birth weight 1200 grams and more; apparently healthy baby; absence of congenital disease; the absence of signs and symptoms suggestive of infection; for example PROM more than 18 hours before birth; maternal fever and positive culture; lack of Cleft palate and cleft lip) Exclusion criteria: (Intraventricular hemorrhage grade 3 or 4 on the third day ultrasonography; diagnosis of Necrotizing enterocolitis; Reported positive blood cultures birth; lack of parental consent to continue the intervention; sepsis while studying, at least 24 hours after starting enteral feeding the baby NPO)
Age
From 1 day old to 2 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
University Ave.
City
Mashhad
Postal code
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.MUMS.REC.1395.337

Health conditions studied

1

Description of health condition studied
weight gain
ICD-10 code
R62.8
ICD-10 code description
Other lack of expected normal physiological development

2

Description of health condition studied
Feeding problems of newborn
ICD-10 code
P92
ICD-10 code description
Feeding problems of newborn

Primary outcomes

1

Description
weight
Timepoint
daily
Method of measurement
balance

2

Description
Feeding Tolerance
Timepoint
During the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
nonnutritive sucking three times a day for 10 minutes in the intervention group
Category
Other

2

Description
Abdominal massage twice a day for 15 minutes in the intervention group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital.
Full name of responsible person
Saideh Marzieh Fazli
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mr. Tafaqodi
Street address
University Ave.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saideh Marzieh Fazli
Position
Nurss/Student
Other areas of specialty/work
Street address
University Ave.
City
Mashhad
Postal code
Phone
00
Fax
Email
m-fazli@bums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Karbandi
Position
Master of nursing
Other areas of specialty/work
Street address
University Ave
City
Mashhad
Postal code
Phone
+98 51 3859 1513
Fax
Email
karbandis@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saideh Marzieh Fazli
Position
Nurss/Student
Other areas of specialty/work
Street address
University Ave.
City
Mashhad
Postal code
Phone
+98 51 3859 1513
Fax
Email
m-fazli@bums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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