1. Home
  2. Approved trials
  3. » فارسی

Effects of non-nutritive sucking on survival gastric residual volume in preterm newborn: A randomized controlled clinical trial

Protocol summary

Summary
The aim of this A randomized controlled clinical trial is to evaluate the effects of non-nutritive sucking on the survival gastric residual volume of gavages in preterm infants. In this study 86 infants with inclusion criteria: ( age between 28-32 weeks ; weight between 750-1500 gm; clinically stable ;no medical contraindications for non-nutritive sucking, No congenital abnormalities and digestive system problems ) and the baby will excluded from the study if occures problems such as : Intraventricular hemorrhage grade 3 and 4 , Periventricular locomalacy , necrotizing enterocolitis , BPD , chronic diseases of the lung, mechanical ventilation , neonatal seizure , positive culture , meningitis , NPO baby for any reason, more than 24 hours. All infants will be randomly selected and divided into two groups. For infants who are in the first group, non-nutritive sucking with pacifier will begin since the beginning of gavages (during gavages) and will continue for 10 minutes after its (the method of gavages will be pushed in all neonates). This practice, three times a day (in the afternoon in hours 3, 5 and 7) will continue for 7 days. Infants in the second group will be gavages on routine ward’s program but they will not be received non-nutritive sucking. In both groups, after initiation of feeding, amount of gastric residual volume, as the primary outcome will be measured at 1 and 2 hours by a syringe during study days and recorded in the relative forms then compared by researcher. It is not possible to blind study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601264613N16
Registration date: 2016-03-03, 1394/12/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-29, 1394/12/10
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of non-nutritive sucking on survival gastric residual volume in preterm newborn: A randomized controlled clinical trial
Public title
Effects of non-nutritive sucking on survival gastric residual volume in preterm newborn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Infants' age between 28-32 weeks; weight between 750-1500 gm; clinically stable infants Physiological indicators including heart rate , respiratory rate and O2 sat ) No medical contraindications for non-nutritive sucking, No congenital abnormalities and digestive system problems by verifying the doctor ordered for gavage feeding, breastfeeding, not the Ventilator Exclusion criteria :If, after entering the study , problems such as : Intraventricular hemorrhage grade 3 and 4 , Periventricular locomalacy , necrotizing enterocolitis , BPD , chronic diseases of the lung, mechanical ventilation , neonatal seizure , positive culture , meningitis , NPO baby for any reason, more than 24 hours the baby will excluded from the study.
Age
To 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz Tabriz East Azerbaijan Iran, Islamic Republic Of 5138947-977
City
Tabriz
Postal code
5138947-977
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
TBZMED.REC.1394.1011

Health conditions studied

1

Description of health condition studied
prematurity
ICD-10 code
Z76.2
ICD-10 code description
Health supervision and care of other healthy infant and child

Primary outcomes

1

Description
Gastric residual volume
Timepoint
One and two hours after gavage
Method of measurement
Using a syringe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Infants who are in this group,non-nutritive sucking with pacifier will begin since the beginning of gavages (during gavages) and will continue for 10 minutes after its (the method of gavages will be pushed in all neonates). This practice, three times a day (in the afternoon in hours 3, 5 and 7) will continue for 7 days.
Category
N/A

2

Description
Control group : Infants who are in this group will be gavages on routine ward’s program but they will not be received non-nutritive sucking.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
poor ashoori – sheryzad
Street address
Educational and Therapeutic Center Al-Zahra , Baghshmal Crossroads, Artesh Street,Tabriz
City
tabriz

2

Recruitment center
Name of recruitment center
29 Bahman hospital
Full name of responsible person
Tagizadeh-zahra
Street address
Tabriz-29 Brahman boulevard
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Deputy of Research and Technology, Tabriz University of Medical Sciences ,Golgasht street , Tabriz, East Azerbaijan, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Tahereh Rafiezadeh
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street , Tabriz , Iran
City
Tabriz
Postal code
51668-44199
Phone
+98 41 3441 8387
Fax
Email
t.rafizadeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sousan Valizadeh
Position
Associate Professor of Child health and Neonatal Intensive Care Department, PhD in Nursing Educatio
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Shariati South Street , Tabriz , Iran Tabriz East Azerbaijan Iran, Islamic Republic Of 51668-44199 00984114790365 00989143098650 00984114796969 valizades@tbzmed.ac.irvalizadehsousan13@gmail.com http://researchvice.tbzmed.ac.ir
City
Tabriz
Postal code
51668-44199
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
valizades@tbzmed.ac.ir valizadehsousan13@gmail.com
Web page address
http://researchvice.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tahereh Rafiezadeh
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street , Tabriz , Iran Tabriz East Azarbaijan Iran, Islamic Republic Of
City
Tabriz
Postal code
51668-44199
Phone
+98 41 3479 0364
Fax
+98 41 3479 0364
Email
t.rafizadeh@gmail.com
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
Loading...