Protocol summary

Summary
Objectives:To determine the effect of erythromycin on the establishment of feeding in infants under 32 weeks gestation. Design:randomized, double-blind, clinical trial; Study population: 40 preterm infants under 32 weeks gestation hospitalized in the neonatal intensive care unit with a diagnosis of dietary intolerance randomly divided into two groups; Study type: one center; Study phase: Phase II. Setting and conduct: The first group (n=20) that Erythromycin ethyl succinate oral (10 mg per kg every six hours to two days, followed by 4 mg per kg every six hours to 5 days) and group II (n=20) treated with normal saline will receive the same dose and instructions. The duration of treatment for both groups will be equivalent to one week. Participants: Inclusion criteria : Infants less than 32 weeks gestational age or weighting less than 1800 g and the minimum age is 5 days after birth and are clinically stable economical state (normal blood pressure Episodes of bradycardia and hypoxemia not) feeding intolerance for less than 75 milli liters per kilogram per day 14 days remain gay or gastric material by more than 50% of 3 hours, which occurred at least two times during the 24 hour period or more than 30% of gastric residues 3 hours ago happened at least three times. Exclusion criteria : lethal congenital malformations congenital or chromosomal disorders, cyanotic heart disease, diseases of the gastrointestinal tract obstruction (mal rotation, atresia and Omphalocele, etc.), gastrointestinal surgeries in 14 days ago, NEC suspected or confirmed in the last 7 days, definite or clinical sepsis, metabolic disorders or electrolytic , and treatment with any of the following medications at the onset of feeding intolerance fentanyl , indomethacin , pancuronioum. Interventions : The use of erythromycin ethylene succinate in the study group. Main outcome: Infant can tolerate 150 milliliter per kilogram in at least 24 hours in one day; side effects of treatment include diarrhea, vomiting, pyloric stenosis and evidence of necrotizing enterocolitis; the length of stay in ICU and hospital.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121925591N1
Registration date: 2016-06-12, 1395/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-12, 1395/03/23
Registrant information
Name
Maryam Saboute
Name of organization / entity
Akbar abadi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 2277
Email address
saboute.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences Research Center
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomize clinical trial on determining the effect of Erythromycin on the establishment of feeding in infants under 32 weeks gestation
Public title
Influence of Erythromycin ethyl succinate oral on establishment of feeding in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infants less than 32 weeks gestational age or weighting less than 1800 g with minimum age of 5 days and clinically stable (Normal blood pressure, not having episodes of bradycardia and hypoxemia); Feeding intolerance for less than 75 milliliters per kilogram per day in 14 days; material remaining in the stomach for more than 50% in 3 hours before, which occurred at least two times during the 24 hours; Vomiting more than 30% of gastric residues in 3 hours that happened at least three times Exclusion criteria: Lethal congenital malformations congenital or chromosomal disorders; Cyanotic heart disease; Diseases of the gastrointestinal tract obstruction (Mal rotation, Atresia and Omphalocele, etc.); Gastrointestinal surgeries in 14 days ago; NEC suspected or confirmed in the last 7 days; Definite or clinical sepsis; Metabolic disorders or electrolytic; Treatment with any of the following medications at the onset of feeding intolerance (Fentanyl , Indomethacin, Pancuronioum)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Ethics Committee of Iran University of Medical Sciences, School Medicine
Street address
Iran University of Medical Sciences , Hemmat high way , Tehran , Iran
City
Tehran
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
IR.IUMS.REC.1394-22688

Health conditions studied

1

Description of health condition studied
Premature infants
ICD-10 code
P78.9
ICD-10 code description
Perinatal digestive system disorder, unspecified

Primary outcomes

1

Description
Feeding tolerance of preterm infants
Timepoint
5 days after birth less than 32 weeks, less than 1800 gr
Method of measurement
Weight

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Erythromycin Ethyl Succinate oral (10 mg per kg every six hours to two days, followed by 4 mg per kg every six hours to 5 days)
Category
Treatment - Drugs

2

Description
Control group: Normal saline (placebo) (10 mg per kg every six hours to two days, followed by 4 mg per kg every six hours to 5 days)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Children Hospital,
Full name of responsible person
Dr.Maryam Saboute
Street address
Ali Asghar Children Hospital, Vahid Dastgerdi St., Shariati Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences Research Center
Full name of responsible person
Dr. Seyed Ali Javad Mousavi
Street address
3rd floor, Setad building, in front of Milad Hospital, Hemat
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences Research Center
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
Ali Asghar Children Hospital
Full name of responsible person
Maryam Saboute
Position
Assistant professor, Neonatologist
Other areas of specialty/work
Street address
Ali Asghar Children Hospital, Vahid Dastgerdi St.,Shariati Ave
City
Tehran
Postal code
Phone
+98 21 5563 2277
Fax
Email
saboutem@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ali Asghar Children Hospital
Full name of responsible person
Maryam Saboute
Position
Assistant Professor
Other areas of specialty/work
Street address
Ali Asghar Children Hospital, Vahid Dastgerdi St.,Shariati Ave
City
Tehran
Postal code
Phone
+98 21 5563 2277
Fax
Email
saboutem@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ali Asghar Children Hospital
Full name of responsible person
Dr.Maryam Saboute
Position
Assistant Professor, Neonatologist
Other areas of specialty/work
Street address
Ali Asghar Children Hospital, Vahid Dastgerdi St., Shariati Ave
City
Tehran
Postal code
Phone
+98 21 5563 2277
Fax
Email
saboutem@yahoo.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
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