Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000434291
Ethics application status
Approved
Date submitted
29/01/2018
Date registered
26/03/2018
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preterm growth failure after birth
Scientific title
Incidence of postnatal growth restriction in preterm infants at Dubai hospital
Secondary ID [1] 293892 0
Nil
Universal Trial Number (UTN)
U1111-1208-6391
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post natal growth restriction
 306363 0
Condition category
Condition code
Diet and Nutrition 305447 305447 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 305745 305745 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The nutritional management of preterm infants represents a crucial challenge for most of practitioners caring of sick premature babies. And despite the aggressive parenteral and enteral alimentation, yet a considerable number still fall far beyond the expected growth indices that match infants of similar gestation in-utero. The incidence of post-natal growth restriction (PNGR) varied and ranged from 37% to 67% in preterm infants.
PNGR can have detrimental neurodevelopmental outcome and cognitive impairment during later stages of life.
The purpose of this observational study is to evaluate the nutritional strategy and explore the incidence of PNGR among preterm infants admitted to NICU, Dubai Hospital.
Preterm infants<32 weeks and birth weight <1500gm will be subjected to serial measurments of growth indices mainly weight, length and head circumference on weekly basis after birth till time of discharge or when reaching 40 weeks corrected age. The caloric intake either enteral or parentral via TPN will be calculated and recorded including all the constiuents of parentral nutrition.
Intervention code [1] 300161 0
Diagnosis / Prognosis
Intervention code [2] 300162 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304593 0
The percentage of post-natal growth restriction among preterm infants admitted to NICU including the weight. Assessment of weight by electronic weight scale at NICU and to be plotted on Fenton growth chart for preterm infants
Timepoint [1] 304593 0
at 40 weeks of corrected gestational age or time of discharge
Primary outcome [2] 304819 0
The percentage of post-natal growth restriction among preterm infants admitted to NICU including the length. Assessment of length by measuring tape, and to be plotted on Fenton growth chart for preterm infants
Timepoint [2] 304819 0
At the age of 40 weeks of corrected gestational age or the time of discharge
Primary outcome [3] 304820 0
The percentage of post-natal growth restriction among preterm infants admitted to NICU including the head circumference. Assessment of head circumference by head circumferenc at NICU and to be plotted on Fenton growth chart for preterm infants
Timepoint [3] 304820 0
at the age of 40 weeks of corrected gestational age or the time of discharge.
Secondary outcome [1] 342471 0
Proportion of preterm infants received energy supply of 120 Kcal/kg/d. Assessment will be by the individual calculation of caloric supply for each nutritional element involved in TPN supply ( glucose, amino acids and fat) as well as calories gained from breast or formula milk supply via enteral feeding and or the human milk fortifiers.
Timepoint [1] 342471 0
on weekly basis till 40 weeks corrected gestational age or discharge time

Eligibility
Key inclusion criteria
All preterm infants with gestational age ranging from 24- 32 weeks and birth weight of 500 gram- 1499 gram admitted to NICU Dubai hospital during the study period.
Minimum age
1 Hours
Maximum age
16 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- infants with major congenital abnormalities.
2-infants with antenatal diagnosis of small for gestational age (SGA).
3-infants more than 32 weeks gestation, or birth weight more than 1500 gram.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
-Sample size determined based on admission rate of preterm infants less than 32 weeks in NICU Dubai hospital during the trial period of 12 month.
-The numerical variables will be expressed as median and range, and compared using the Mann-Whitney U test, or the mean and standard deviation, compared using the Student’s t test. The categorical variables will be expressed as numbers and percentages, and compared using the chi-square or Fisher’s exact test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2018
Actual
5/04/2018
Date of last participant enrolment
Anticipated
26/09/2019
Actual
Date of last data collection
Anticipated
26/09/2019
Actual
Sample size
Target
200
Accrual to date
55
Final
Recruitment outside Australia
Country [1] 9531 0
United Arab Emirates
State/province [1] 9531 0
Dubai

Funding & Sponsors
Funding source category [1] 298515 0
Hospital
Name [1] 298515 0
Dubai Hospital
Country [1] 298515 0
United Arab Emirates
Primary sponsor type
Hospital
Name
Dubai hospital
Address
NICU, DUBAI HOSPITAL.
THIRD FLOOR.
ALBARAHA, Alkornisch street No.1.
DUBAI 7272
UAE.
Country
United Arab Emirates
Secondary sponsor category [1] 297662 0
Individual
Name [1] 297662 0
Atef Alshafei
Address [1] 297662 0
NICU, DUBAI HOSPITAL.
THIRD FLOOR.
ALBARAHA, Alkornisch street No.1.
DUBAI 7272
UAE.
Country [1] 297662 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299493 0
Dubai scientific research ethics committee DSREC
Ethics committee address [1] 299493 0
Dubai Scientific Research Ethics Committee DSREC
DSREC
CONTINUOUS MEDICAL EDUCATION DEPARTMENT
RASHID MEDICAL LIBRARY
PO BOX 4545
DUBAI.
UAE
Ethics committee country [1] 299493 0
United Arab Emirates
Date submitted for ethics approval [1] 299493 0
11/10/2017
Approval date [1] 299493 0
14/12/2017
Ethics approval number [1] 299493 0
DSREC-10-2017-10

Summary
Brief summary
Postnatal growth restriction (PNGR) is a common problem facing neonatologists in the era of improved survival of extreme preterm infants. Considerable number of preterm infants fail to achieve the intrauterine growth accretion parameters after birth inspite of aggressive nutritional strategies carried by NICU staff. PNGR is a potential risk factor for the future neurodevelopmental outcome of preterm infants. The objective of the current prospective observational study is to evaluate the incidence of PNGR at NICU, Dubai Hospital with assessment of all growth parameters namely weight, head circumference, and length. Evaluation will be on weekly basis starting since birth till the age of 40 weeks corrected gestational age or the time of discharge. The secondary outcome is to evaluate the nutritional strategy adopted by NICU to achieve the desired caloric intake either by parentral nutrition or enteral intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80602 0
Dr Atef Alshafei
Address 80602 0
ATEF ALSHAFEI
NICU, DUBAI HOSPITAL
THIRD FLOOR.
ALBARAHA, Alkornisch street No.1.
DUBAI 7272.
UAE
Country 80602 0
United Arab Emirates
Phone 80602 0
+971561924270
Fax 80602 0
Email 80602 0
[email protected]
Contact person for public queries
Name 80603 0
Dr Atef Alshafei
Address 80603 0
ATEF ALSHAFEI
NICU, DUBAI HOSPITAL
THIRD FLOOR.
ALBARAHA, Alkornisch street No.1.
DUBAI 7272.
UAE
Country 80603 0
United Arab Emirates
Phone 80603 0
+971561924270
Fax 80603 0
Email 80603 0
[email protected]
Contact person for scientific queries
Name 80604 0
Dr Atef Alshafei
Address 80604 0
ATEF ALSHAFEI
NICU, DUBAI HOSPITAL
THIRD FLOOR.
ALBARAHA, Alkornisch street No.1.
DUBAI 7272.
UAE.
Country 80604 0
United Arab Emirates
Phone 80604 0
+971561924270
Fax 80604 0
Email 80604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial.
When will data be available (start and end dates)?
One month following main results publication. No end dates.
Available to whom?
case by case basis
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23601Ethical approvalnil [email protected] nil 374386-(Uploaded-06-03-2020-08-12-02)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.