Purpose of the study: To determine the effectiveness of clinical outcomes of early nutritional support at infant with esophageal atresia. A not blind, block randomized clinical trial.
Study population: Infants with esophageal atresia who will have surgical repair at doctor Sheikh Hospital.
Inclusion criteria: Children with esophageal atresia type C; gestational age over 34 weeks; not have other major abnormalities addition of atresia; in the first group classification of spitz; distance less than 3 cm between two blind bags in atresia; weighing patients over1800 grams; children have physiological stability.
Exclusion criteria: Dependence on the ventilator and delayed weaning from mechanical ventilation for more than 48 hours; clinical symptoms of Anastomotic leakage in the first 48 hours after surgery.
Sample size: 36 cases.
Study intervention: Feeding 48 hours after surgical repair of esophageal atresia.
Intervention time: 48 hours after surgical repair of esophageal atresia.
The outcome of the study: To determine the effectiveness of early feeding on feeding tolerance, length of hospitalized, Anastomotic stricture, Anastomotic leakage and weighting to improve at groups cases.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110524893N1
Registration date:2016-05-02, 1395/02/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-02, 1395/02/13
Registrant information
Name
marzieh ghorbani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3753 4374
Email address
ghorbanim8@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To determine the effectiveness of clinical outcomes of early nutritional support at infant with esophageal atresia
Public title
Effectiveness of early nutrition in infants with esophageal atresia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Children with esophageal atresia type C; gestational age over 34 weeks; not have other major abnormalities addition of atresia; in the first group classification of spitz; distance less than 3 cm between two blind bags in atresia; weighing patients over1800 grams; children have physiological stability.
Exclusion criteria: Dependence on the ventilator and delayed weaning from mechanical ventilation for more than 48 hours; clinical symptoms of Anastomotic leakage in the first 48 hours after surgery.
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
99191-91778
Approval date
2015-07-04, 1394/04/13
Ethics committee reference number
IR.MUMS.REC.1394.246
Health conditions studied
1
Description of health condition studied
Esophageal atresia
ICD-10 code
Q39.1
ICD-10 code description
آترزی مری با فیستول تراشه
Primary outcomes
1
Description
length of hospitalized
Timepoint
After intervention until discharge from hospital
Method of measurement
Questionnaire
2
Description
Anastomotic leakage
Timepoint
After intervention until discharge from hospital
Method of measurement
X-ray
3
Description
weighting to improve
Timepoint
After intervention until one month after discharge from hospital
Method of measurement
Balance
4
Description
Feeding tolerance
Timepoint
After the intervention, one month after discharge from hospital
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Anastomotic stricture
Timepoint
One month after discharge from hospital
Method of measurement
Endoscopy
Intervention groups
1
Description
Feeding 48 hours after surgical repair of esophageal atresia
Category
Other
2
Description
The control group: Did not do anything
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Sheikh Hospital
Full name of responsible person
Gholamreza khademi
Street address
Doctor Sheikh Hospital, Manoochehri
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
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
Akram Rezaeian
Position
Master of Pediatric Nursing
Other areas of specialty/work
Street address
Dr Shekh Hospital, Manoochehri
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
RezaeianA@mums.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
Gholamreza khademi
Position
Pediatrician
Other areas of specialty/work
Street address
Dr Shekh Hospital, Manoochehri
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
khademigh@ 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
Marzieh Ghorbani
Position
Master of Neonutal Nursing
Other areas of specialty/work
Street address
Mousavi Ghouchani Boulevard ; Housing askan
City
Mashhad
Postal code
9196674546
Phone
+98 51 3753 4374
Fax
Email
ghorbanim8@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)