Protocol summary

Summary
Infants with birth weight less than 1000 g hospitalized in NICU in Akbarabadi Hospital, Tehran, Iran are being screened according to inclusion criteria untill n=32. By using blocking method, infants are divided into 2 groups of receiving protein supplements (Aptamil protein supplement) and receieving no protein diet. Concealment is in a way that the method of intervention is not disclosed until it is performed. This is a double-blind study (patient and analizer). Infants in control group with 100-120 kcal/kg/day receive enteral feeding evey 2-3 hours. Calorie intake is adjusted according to daily weight gain. In treatment group receiving protein, 0.6-0.8 gr/kg/day protein supplement is added to daily milk and is adjusted according to daily weight gain and weekly measurment of BUN, Cr, and Alb. The amount of receieved protein and calorie intestinally for each infant is calculated and recorded. Daily nutritional data are recorded until infant’s weight reaches 1500 g. The increase of BUN and the mean increase of necrotizing enterocolitis as a consequence of protein supplement in control group are compared with those of treatment group. Primary outcome: daily measurment of weight, weekly measurment of height and head circumference to assess infant growth Secondary outcomes: The incidence of morbidity, such as necrotizing enterocolitis, and increased kidney load as a result of increased BUN and Cr are recorded.

General information

Acronym
Protein supplementation, very low birth weight
IRCT registration information
IRCT registration number: IRCT2016013126115N2
Registration date: 2016-05-25, 1395/03/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Mandana Kashaki
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 2277
Email address
kashakimd@gmail.com
Recruitment status
Recruitment complete
Funding source
Faculty of Medicine, Iran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of protein supplementation on growth of infants weighing less than 1000 g hospitalized in the neonatal intensive care unit Akbar Abadi Hospital in Tehran, in 2014- 2015
Public title
The effect of protein supplementation on growth of infants weighing less than 1000 g hospitalized in the neonatal intensive care unit Akbar Abadi Hospital in Tehran, in 2014-2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion citeria: infants with birth wieght less than 1000 g who recieve 100-120 cc/kg/day milk and their parenteral feeding discontinued; infants with major congenital abnormalities, confirmed or suspected necrotizing enterocolitis before recieving protein supplements; infants who do not require a major surgery; infants without intrauterine infections that inhibit growth, or genetic diseases that lead to poor growth. Exclusion criteria: if BUN exceedes 25 or necrotizing enterocolitis symptoms appear or we have to NPO the newborn baby due to medical conditions, s/he will be excluded.
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat High way
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.IUMS.REC.1394.9311165002

Health conditions studied

1

Description of health condition studied
Very low birth weight
ICD-10 code
P07.0
ICD-10 code description
Extremely low birth weight

Primary outcomes

1

Description
Head circumference
Timepoint
weekly until neonates weight get to 1500 gram.
Method of measurement
meter

2

Description
Weight
Timepoint
weekly until neonates weight get to 1500 gram.
Method of measurement
Scale

3

Description
Height
Timepoint
weekly until neonates weight get to 1500 gram.
Method of measurement
Meter

Secondary outcomes

1

Description
Neonatal entrocolitis
Timepoint
when neonates weight get to 1500 gram.
Method of measurement
Clinical examination

2

Description
Blood urea nitrogen
Timepoint
when neonates weight get to 1500 gram.
Method of measurement
Blood test

3

Description
Creatinine
Timepoint
when neonates weight get to 1500 gram.
Method of measurement
Blood test

Intervention groups

1

Description
In intervention group protein supplement to 0.8-0.6 gr / kg / day is added to milk daily and based on the daily weight gain and check of BUN, Cr and Alb is set on a weekly basis until the weight of nenonates get 1500 grams.
Category
Treatment - Other

2

Description
In infants in the control group kcal / kg / day 100-120 divided done every 2 to 3 hours enteral nutrition. Based on the amount of calories daily weight gain is adjusted.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Street address
Shahid Akbar Abadi hospital, Ferdowsi Station, Molavi st.
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Medicine, Iran University of Medical Sciences
Full name of responsible person
Leili Irani
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medicine, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zahra Behnamfar
Position
MD, Pediatrics resident
Other areas of specialty/work
Street address
23 unit, Yasaman avn., Beheshti complex, Babaei highway
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 7711 8969
Fax
Email
z_behnamfar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Akbar Abadi hospital
Full name of responsible person
Mandana Kashaki
Position
Assistant proffesor
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Ferdowsi Station, Molavi st.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 5563 2277
Fax
Email
kashakimd@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Behnamfar
Position
Md, Pediatrics resident
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Ferdowsi Station, Molavi st.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 7711 8969
Fax
Email
z_behnamfar@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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