Early outcome of Extremely Low Birth Weight Infants before and after Establishment of Palliative Care protocol according to Clinical Risk Index for Babies scoring system (CRIB II)
1- Establishment of the palliative care protocol for extremely low birth weight (ELBW) infants with Clinical Risk Index for Babies II (CRIB II) score more than 15
2-Determining of CRIB II for ELBW infants
3 - Evaluation of short-term outcome in ELBW infants
Design
Two arm parallel-group, double-blinded non-randomized trial
Settings and conduct
Preterm ELBW infants hospitalized in the newborn intensive care unit (NICU) of Tabriz Alzahra Hospital who have CRIB II scores more than 15 will receive palliative care including thermal support, intravenous fluid therapy, and respiratory support. The control group will also receive mechanical ventilation and surfactant therapy. The Infants of both groups will be followed until discharge and the outcomes of the groups will be compared. Nurses and the analyzer of data will not aware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Preterm infants with the gestational age of 24/+0 to 26/+6 weeks and birth weight of 500 to 750 grams born in Tabriz Alzahra Hospital.
Exclusion criteria: Preterm Infants who will be deceased in delivery or operation rooms, with major anomalies or major birth defects, gestational age less than 23 weeks and 6 days or more than 27 weeks, birth weight more than 750 grams
Intervention groups
Preterm ELBW infants with CRIB II score more than 15 will receive palliative care including thermal support, intravenous fluid therapy, and respiratory support. The control group will also receive mechanical ventilation and surfactant therapy.
Main outcome variables
Short-term outcome including mortality rate; necrotizing enterocolitis grade 2 or more; retinopathy of prematurity; cerebral hemorrhage with grade 2 or more
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100607004113N18
Registration date:2020-04-18, 1399/01/30
Registration timing:registered_while_recruiting
Last update:2020-04-18, 1399/01/30
Update count:0
Registration date
2020-04-18, 1399/01/30
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early outcome of Extremely Low Birth Weight Infants before and after Establishment of Palliative Care protocol according to Clinical Risk Index for Babies scoring system (CRIB II)
Public title
Effect of Palliative Care protocol on mortality and morbidity of Extremely Low Birth Weight Infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Extremely Low Birth Weight preterm infants with gestational age of ( 24 weeks+0 Day) to ( 26 weeks+6 Days)
Birth weight between 500- 750 grams
Inborn and admitted in Neonatal Intensive Care Unit of Alzahra teaching hospital of Tabriz
Exclusion criteria:
Born after assisted reproductive technology or In vitro fertilization (IVF)
Infants born with major anomalies or birth defects
Gestational age less than 24 Weeks or more than 27 weeks of gestation
Infants who's parents aren't agreed with palliative care
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
research nurse who are blinded to groups . Analyzer of the data also will be blind to the groups of infants
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tabriz University of Medical Sceinces
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.TBZMED.REC.1398.1070
Health conditions studied
1
Description of health condition studied
Extreme immaturity of newborn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mortality of ELBW neonate before and after Establishment of palliative care protocol according to (CRIB II) scoring system
Timepoint
From birth to discharge from hospital or death
Method of measurement
Questioner and evaluation of vital sign
Secondary outcomes
1
Description
Necrotizing enterocolitis (NEC) satge 2 or more
Timepoint
From birth until discharge from hospital
Method of measurement
Questioner and Bell's stage
2
Description
Retinopathy of Prematurity need intervention ( Photocoagulation or Evastin injection )
Timepoint
From 28 days after birth until discharge from hospital
Method of measurement
Questioner and Revised International Classification of ROP (ICROP)
3
Description
Intraventricular Hemorrhage Grade 2 or more
Timepoint
During first week of life
Method of measurement
Brain ultrasonography
Intervention groups
1
Description
Preterm infants in two parallel groups include in the non randomized study , Intervention group are infants who have score of 15 or more according to Clinical Risk Index for Babies scoring system (CRIB II) .After consent of the parents This group of patients will receive palliative care consist of :thermal stabilization ,respiratory support as Nasal Continues Positive Airway Pressure , use of intravenous antibiotics consist of Ampicillin and Gentamicin( according to the guideline of the unit) and Total Parenteral Nutrition.
Category
Other
2
Description
Control group: are preterm infants who have score of less than 15 according ( CRIB II )scoring system .This group of infants will receive full support care consist of : thermal stabilization ,respiratory support as Nasal Continues Positive Airway Pressure and Mechanical ventilation if needed , use of intravenous antibiotics consist of Ampicillin and Gentamicin( according to the guideline of the unit) , Total Parenteral Nutrition and Surfactant therapy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra teaching hospital of Tabriz
Full name of responsible person
MohammadBagher Hosseini
Street address
Alzahra teaching hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3334 4280
Fax
+98 41 3556 6449
Email
info@alzahrahosp.tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei DDS, MSc
Street address
Golgasgt
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadbagher Hosseini
Position
Associate Professor of Pediatric Departement
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
hosseini.neo@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadbagher Hosseini MD
Position
Associate professor of Pediatric Departement
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
hosseini.neo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadbagher Hosseini
Position
Associate Professor of Pediatric Departement
Latest degree
Subspecialist
Other areas of specialty/work
Neonatologist
Street address
Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
hosseini.neo@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This study is in the first steps and may be repeated in other centers without ethical considerations