Protocol summary

Summary
Objective: this study attempts to determine effects abdominal massage could have on feeding tolerance in preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU) in certain hospitals of Isfahan in 2015. Study design: randomized controlled trial. Study population: the population consisted of infants who were hospitalized in the NICU, were in the 28-32 week-old age range, weighed 1000-1800 grams, and had all inclusion criteria. Inclusion criteria: infants should be in the 28-32 week-old age range; infants should weigh1000-1800 grams; infants who have a medical prescription for a daily feeding of at least 20 cc/kg; infants who are breastfed; infants who suffer from feeding intolerance; infants should have no history of ileus (gastrointestinal atony), abdominal surgery, or any other problem forbidding them to receive abdominal massage; infants should be fed through the orogastric tube; parents should give consent to the examination of their infants; preterm infants should never suffer from major congenital anomalies such as congenital heart disease, digestive-system disorders, hypoxic injury, respiratory failure with mechanical ventilation, history of necrotizing enterocolitis (NEC), or (suspected) sepsis; preterm infants should show no symptoms of intracranial hemorrhage; preterm infants should never need a ventilator. Exclusion criteria: parents’ withdrawal for infants’ participation in the study; infants’ discharge or death before the end of the intervention period; infants’ becoming unwell in the course of illness and during the study, which would interfere with the intervention for any reason. Sample size: 64 (32 in the intervention group and 32 in the control group). Study intervention(s): abdominal massage. Primary outcome variables: gastric residual volume, abdominal circumference, vomiting frequency, and defecation frequency.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072723216N3
Registration date: 2016-08-26, 1395/06/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-26, 1395/06/05
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Science
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Abdominal Massage on Feeding Tolerance in Preterm Infants in Certain Hospitals of Isfahan
Public title
Effects of Abdominal Massage on Feeding Tolerance in Preterm Infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: infants should be in the 28-32 week-old age range; infants should weigh1000-1800 grams; infants who have a medical prescription for a daily feeding of at least 20 cc/kg; infants who are breastfed; infants who suffer from feeding intolerance; infants should have no history of ileus (gastrointestinal atony), abdominal surgery, or any other problem forbidding them to receive abdominal massage; infants should be fed through the orogastric tube; parents should give consent to the examination of their infants; preterm infants should never suffer from major congenital anomalies such as congenital heart disease, digestive-system disorders, hypoxic injury, respiratory failure with mechanical ventilation, history of necrotizing enterocolitis (NEC), or (suspected) sepsis; preterm infants should show no symptoms of intracranial hemorrhage; preterm infants should never need a ventilator. Exclusion criteria: parents’ withdrawal for infants’ participation in the study; infants’ discharge or death before the end of the intervention period; infants’ becoming unwell in the course of illness and during the study, which would interfere with the intervention for any reason.
Age
To 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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 Isfahan University Of Medical Sciences
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan,
Postal code
8174673461
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
Ir.mui.rec.1395.3.001

Health conditions studied

1

Description of health condition studied
Feeding Tolerance inInfants
ICD-10 code
P92.8
ICD-10 code description
Other feeding problems of newborn

Primary outcomes

1

Description
Gastric residual volume
Timepoint
Before and after intervention
Method of measurement
with syring

2

Description
Abdomen circumferenc
Timepoint
Before and after intervention
Method of measurement
With meter

3

Description
Vomiting
Timepoint
Every working shift
Method of measurement
Frequency

4

Description
Defecation
Timepoint
Every working shift
Method of measurement
Frequency

Secondary outcomes

empty

Intervention groups

1

Description
Giving infants abdominal massage one hour after feeding them for 10 minutes twice a day and repeating it for 5 days.
Category
Other

2

Description
No intervention was performed in the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Isahan

2

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medcal Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Isfahan University of Medcal Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfahan
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, Isfahan University of Medcal 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
Isfahan University of Medical Sciences
Full name of responsible person
Mahin Shaeri
Position
Master Science of Nursing
Other areas of specialty/work
Street address
No. 44, Tus Blvd., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3257 6309
Fax
Email
mahinshaeri2013@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
PhD
Other areas of specialty/work
Street address
No.127, 22 Bahman alley, Raran st., Khorasgan city, Isfahan, Iran
City
Khorasgan
Postal code
Phone
+98 31137927561
Fax
Email
ghadami@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Amini Rarani Said
Position
Master Science of Nursing
Other areas of specialty/work
Street address
No.127, 22 Bahman alley, Raran st., Khorasgan city, Isfahan, Iran
City
Khorasgan
Postal code
8159314853
Phone
+98 31 3522 6158
Fax
Email
Aminix11@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
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