Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001569796
Ethics application status
Approved
Date submitted
28/11/2022
Date registered
19/12/2022
Date last updated
19/12/2022
Date data sharing statement initially provided
19/12/2022
Date results information initially provided
19/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Administration of parenteral nutrition in preterm newborns
Scientific title
Delayed versus early macronutrients’ target achievement of preterm newborns: a randomized controlled trial
Secondary ID [1] 308442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenteral nutrition 328238 0
Preterm newborns 328239 0
Condition category
Condition code
Diet and Nutrition 325289 325289 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 325290 325290 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of parenteral nutrition, administered by a neonatal physician, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with birth weight less than 1000 g in Group 2: time of energy target dose achievement (100-110 kcal/kg/day), at 10-12 days of life; time of amino acids target dose achievement (3.5- 4.0 g/kg/day), at 5-7 days of life; time of dextrose target dose achievement (13.0 - 14.0 g/kg/day), at 10-12 days of life; time of lipids target dose achievement (3.5-4.0 g/kg/day), at 5-7 days of life. For newborns with birth weight equal or greater than 1000 g in the Group 2: time of energy target dose achievement (90-100 kcal/kg/day), at 10-12 days of life; time of amino acids target dose achievement (3.5-4.0 g/kg/day), at 5-7 days of life; time of dextrose target dose achievement (13.0-14.0 g/kg/day), at 10-12 days of life; time of lipids target dose achievement (3.0-3.5 g/kg/day), at 5-7 days of life.
Intervention code [1] 324889 0
Treatment: Other
Comparator / control treatment
Intravenous administration of parenteral nutrition, administered by a neonatal physician, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with birth weight less than 1000 g in Group 1: time of energy target dose achievement 100-110 kcal/kg/day, at 4-5 days of life; time of amino acids target dose achievement (3.5- 4.0 g/kg/day), at 3-4 days of life; time of dextrose target dose achievement (13.0 - 14.0 g/kg/day), at 5-7 days of life; time of lipids target dose achievement (3.5-4.0 g/kg/day), at 3-5 days of life. For newborns with birth weight equal or greater than 1000 g in Group 1: time of energy target dose achievement (90-100 kcal/kg/day), at 4- 5 days of life; time of amino acids target dose achievement (3.5-4.0 g/kg/day), at 3-4 days of life; time of dextrose target dose achievement (13.0-14.0 g/kg/day), at 5-7 days of life; time of lipids target dose achievement (3.0-3.5 g/kg/day), at 3-5 days of life.
Control group
Active

Outcomes
Primary outcome [1] 333176 0
The rate of patients experiencing hyperglycemia assessed by blood test on the participants.
Timepoint [1] 333176 0
At least one episode of hyperglycemia, defined as two consecutive blood glucose levels greater than 180 mg/dL, at least 3 hours apart, within the first week of life.
Secondary outcome [1] 416056 0
Nil
Timepoint [1] 416056 0
Nil

Eligibility
Key inclusion criteria
Newborns with gestational age < 32 weeks or with birth weight <1500 g
Minimum age
0 Days
Maximum age
3 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates with major congenital malformations, inborn errors of metabolism, congenital infections, hospital discharge or death within 24 hours of life.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Statistician was blinded to study aims and the patient codes were revealed after statistical analysis.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis performed using Statistical Package for Social Science Software for Microsoft Windows (SPSS Inc, Chicago, IL, USA), version 27.0. We checked for normality using a Shapiro-Wilk test. The mean and standard deviation or median summarized continuous variables. We used a chi-square test for categorical variable, t-test, Mann-Whitney and Wilcoxon test for paired and unpaired variables. The analysis on primary outcome was performed per intention to treat. We performed a binary regression analysis to study the possible influence of cofounding variables on the occurrence of hyperglycemia. The influence of covariates on the occurrence of mortality and morbidity rate was evaluated by logistic regression analysis. The level of significance for all statistical tests was 2-sides (p < 0.05). We estimated the need of 177 participants in each group to obtain a power of 90% (type 1 error=0.05, two tailed test, drop out 10%).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2018
Date of last participant enrolment
Anticipated
Actual
1/10/2021
Date of last data collection
Anticipated
Actual
1/11/2022
Sample size
Target
370
Accrual to date
Final
353
Recruitment outside Australia
Country [1] 25155 0
Italy
State/province [1] 25155 0
Rome

Funding & Sponsors
Funding source category [1] 312688 0
University
Name [1] 312688 0
University of Rome "La Sapienza"
Country [1] 312688 0
Italy
Primary sponsor type
University
Name
University of Rome "La Sapienza"
Address
Piazzale Aldo Moro, 5, 00185, Roma (RM)
Country
Italy
Secondary sponsor category [1] 314302 0
None
Name [1] 314302 0
none
Address [1] 314302 0
none
Country [1] 314302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311990 0
Policlinico Umberto I
Ethics committee address [1] 311990 0
Viale del Policlinico, 155, 00161, Roma (RM)
Ethics committee country [1] 311990 0
Italy
Date submitted for ethics approval [1] 311990 0
01/06/2018
Approval date [1] 311990 0
13/09/2018
Ethics approval number [1] 311990 0
5089

Summary
Brief summary
We hypothesized that delaying the time needed to achieve macronutrients target of supplemental PN, beyond the critical window period (first week of life), even maintaining the same target value recommended, may reduce the occurrence of hyperglycemia in very low birth weight infants. Starting to these considerations, we designed a controlled clinical trial aiming to investigate the efficacy and safety of two PN strategies which were different for the time of target achievement ( Group 1: early target achievement of PN; 2) Group 2: delayed target achievement of PN).


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123086 0
Prof Gianluca Terrin
Address 123086 0
Department of Maternal and Child Health of Policlinico Umberto I, University La Sapienza, Rome, Italy; Viale del Policlinico 155, 00161, Roma (RM)
Country 123086 0
Italy
Phone 123086 0
+39 0649972536
Fax 123086 0
Email 123086 0
Gianluca.terrin@uniroma1.it
Contact person for public queries
Name 123087 0
Prof Gianluca Terrin
Address 123087 0
Department of Maternal and Child Health of Policlinico Umberto I, University La Sapienza, Rome, Italy; Viale del Policlinico 155, 00161, Roma (RM)
Country 123087 0
Italy
Phone 123087 0
+39 0649972536
Fax 123087 0
Email 123087 0
Gianluca.terrin@uniroma1.it
Contact person for scientific queries
Name 123088 0
Prof Gianluca Terrin
Address 123088 0
Department of Maternal and Child Health of Policlinico Umberto I, University La Sapienza, Rome, Italy; Viale del Policlinico 155, 00161, Roma (RM)
Country 123088 0
Italy
Phone 123088 0
+39 0649972536
Fax 123088 0
Email 123088 0
Gianluca.terrin@uniroma1.it

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will be not aivalable


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17698Statistical analysis plan  gianluca.terrin@uniroma1.it attachment 385007-(Uploaded-17-12-2022-05-09-49)-Study-related document.pdf
17699Informed consent form  gianluca.terrin@uniroma1.it attachment 385007-(Uploaded-17-12-2022-05-10-02)-Study-related document.pdf
17702Ethical approval  gianluca.terrin@uniroma1.it attachment 385007-(Uploaded-17-12-2022-05-10-11)-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.