ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parenteral nutrition

Preterm newborns

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

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]

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]

The rate of patients experiencing hyperglycemia assessed by blood test on the participants.

Timepoint [1]

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]

Nil

Timepoint [1]

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?

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]

Italy

State/province [1]

Rome

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Rome "La Sapienza"

Address [1]

Piazzale Aldo Moro, 5, 00185, Roma (RM)

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Policlinico Umberto I

Ethics committee address [1]

Viale del Policlinico, 155, 00161, Roma (RM)

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

01/06/2018

Approval date [1]

13/09/2018

Ethics approval number [1]

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

Prof Gianluca Terrin

Address

Department of Maternal and Child Health of Policlinico Umberto I, University La Sapienza, Rome, Italy; Viale del Policlinico 155, 00161, Roma (RM)

Country

Italy

Phone

+39 0649972536

Fax

Gianluca.terrin@uniroma1.it

Contact person for public queries

Name

Gianluca Terrin

Address

Department of Maternal and Child Health of Policlinico Umberto I, University La Sapienza, Rome, Italy; Viale del Policlinico 155, 00161, Roma (RM)

Country

Italy

Phone

+39 0649972536

Fax

Gianluca.terrin@uniroma1.it

Contact person for scientific queries

Name

Gianluca Terrin

Address

Department of Maternal and Child Health of Policlinico Umberto I, University La Sapienza, Rome, Italy; Viale del Policlinico 155, 00161, Roma (RM)

Country

Italy

Phone

+39 0649972536

Fax

Gianluca.terrin@uniroma1.it

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD will be not aivalable

What supporting documents are/will be available?

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically