Advancing feedings to full enteral feeding is highly difficult and it may last about 2-3 weeks. This study designed to to evaluate the efficacy of metoclopramide in the treatment of feeding intolerance in preterm neonates. 120 preterm infants less than 36 weeks with feeding intolerance and without anomaly include and term neonate and neonate with anomaly exclude and were allocated into two groups: treatment group were received intravenous metoclopramide (0.4mg/kg /day divided 3 times daily,) and control group were received placebo (Sterile water for injection). Full enteral feeding (150 ml/kg/day) after the start of treatment and mean feeding start time, mean time of feeding completion, mean number of vomiting and lavage and mean number of feeding cessations will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305188680N3
Registration date:2014-01-12, 1392/10/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-12, 1392/10/22
Registrant information
Name
Mirhadi Mussavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2094
Email address
mousavi-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of metoclopramide therapy compared with placebo in improving oral feeding intolerance in preterm infants
Public title
Metoclopramide effect in improving feeding tolerance in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Preterm neonate less than 36 weeks with feeding intolerance ; neonate without anomaly; Exclusion criteria : neonate with congenital anomalies
Age
From 3 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Science
Street address
Ilam.Banganjab
City
Ilam
Postal code
Approval date
2012-05-30, 1391/03/10
Ethics committee reference number
EC/92/H/158
Health conditions studied
1
Description of health condition studied
enteral feeding intolerance
ICD-10 code
p78.9
ICD-10 code description
Perinatal digestive system disorder, unspecified
Primary outcomes
1
Description
enteral feeding intolerance
Timepoint
Q3h
Method of measurement
no vomitting,no gastric residua
Secondary outcomes
1
Description
complet full enteral feeding
Timepoint
daily
Method of measurement
volum of feeding per day
Intervention groups
1
Description
Metoclopramide. /13 mg/kg Q 8h intavenously
Category
Treatment - Drugs
2
Description
sterile water for injection ./13 CC q 88 intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Ward , Mostafa Khomeini Hospital , Ilam , Iran
Full name of responsible person
Dr.Mirhadi,Mussavi
Street address
Keshvary sq
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr.Morovat Taheri Kalani
Street address
Banganjab
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University Of Medical Sciences
Full name of responsible person
Mirhadi Mussavi
Position
Assisstant proffesor
Other areas of specialty/work
Street address
Banganjab
City
Ilam
Postal code
Phone
+98 41 1327 2094
Fax
Email
Drmussavihadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of medical sciences
Full name of responsible person
Mirhadi Mussavi
Position
Neonatologist
Other areas of specialty/work
Street address
Banganjab
City
Ilam
Postal code
Phone
+98 84 1222 7126
Fax
Email
Drmussavihadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University Of Medical Sciences
Full name of responsible person
Mirhadi Mussavi
Position
Neonatologist
Other areas of specialty/work
Street address
Ilam
City
Ilam
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)