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Trial registered on ANZCTR

Registration number

ACTRN12619001773123

Ethics application status

Approved

Date submitted

7/09/2019

Date registered

13/12/2019

Date last updated

13/12/2019

Date data sharing statement initially provided

13/12/2019

Date results provided

13/12/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Energy-Enhanced Parenteral Nutrition in preterm newborns

Scientific title

Long term effects of Energy-Enhanced Parenteral Nutrition in preterm newborns

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

preterm newborns

Parenteral Nutrition

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 given by neonatal specialist, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with a birth weight less than 1000 g in the Cohort B: Energy starting dose 45 kcal/kg/day and target dose 105 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 4.0 g/kg/day at 7 days of life; Dextrose starting dose 7.0 g/kg/day and target dose 14.0 at 7 days of life; Lipids starting dose 1.0 g/kg/day and target dose 3.5 at 7 days of life. For newborns with a birth weight greater than or equal to 1000 g in the Cohort B: Energy starting dose 45 kcal/kg/day and target dose 100 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 3.5 g/kg/day at 7 days of life; Dextrose starting dose 7.0 g/kg/day and target dose 14.5 at 7 days of life; Lipids starting dose 1.0 g/kg/day and target dose 3.0 at 7 days of life.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Intravenous administration of parenteral nutrition given by neonatal specialist, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. Data of Cohort A was collected from Policlinico Umberto I records from 1st January 2015 to 31 January 2016. For newborns with a birth weight less than 1000 g in the Cohort A: Energy starting dose 55 kcal/kg/day and target dose 120 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 4.0 g/kg/day at 7 days of life; Dextrose starting dose 7.0 g/kg/day and target dose 16.0 at 7 days of life; Lipids starting dose 2.0 g/kg/day and target dose 4.0 at 7 days of life. For newborns with a birth weight greater than or equal to 1000 g in the Cohort A: Energy starting dose 60 kcal/kg/day and target dose 110 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 3.5 g/kg/day at 7 days of life; Dextrose starting dose 8.5 g/kg/day and target dose 15 at 7 days of life; Lipids starting dose 2.0 g/kg/day and target dose 3.5 at 7 days of life.

Control group

Historical

Outcomes

Primary outcome [1]

Body weight measured by digital scale

Timepoint [1]

At 24 months of life.

Primary outcome [2]

Head circumference measured by tape measurement

Timepoint [2]

At 24 months of life.

Primary outcome [3]

Length measured from the top of the head to the sole of the feet, using a neonatal stadiometer,

Timepoint [3]

At 24 months of life.

Secondary outcome [1]

The rate of patients with Extrauterine growth retardation (EUGR), defined as a reduction in percentiles >2.0 SD in body weight (measured by digital scale). between birth and 36 weeks of postmestrual age (PMA), according with INeS charts (http://inescharts.com).

Timepoint [1]

At 36 weeks of PMA

Eligibility

Key inclusion criteria

Newborns with gestational age <32 weeks or with birth weight <1500 g,

Minimum age

0 Days

Maximum age

2 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Infants with major congenital malformations, inborn errors of metabolism, congenital infections, hospital discharge or death within 72 hours of life.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

This study compared two Cohorts of newborns, consecutively observed during two different periods in NICU of Policlinico Umberto I, receiving different energy intakes through PN in the first weeks of life. Cohort A included newborns observed from the 1st of January 2015 to 31 January 2016 (historical control), and Cohort B included newborns observed from the 1st of February 2016 to 31 March 2017 (intervention). We provided a clinical follow-up to evaluate growth until 24 months of adjusted age for both Cohorts of the study.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical analysis performed using Statistical Package for Social Science software for Microsoft Windows (SPSS Inc, Chicago, IL), version 22.0. Check for normality using Shapiro-Wilk test. The mean and standard deviation or median and interquartile range summarised continuous variables. Cohorts compared using chi-square test for categorical variable and t-test or Mann-Whitney for paired and unpaired variables. Multivariate analysis using binary logistic regression analysis to evaluate whether GA, sex, pH of cord blood at birth or PN protocol, influenced growth at 36 weeks PMA and at 24 months of life. The level of significance for all statistical tests: 2-sides (p<0.05).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/01/2015

Date of last participant enrolment

Anticipated

Actual

31/03/2017

Date of last data collection

Anticipated

Actual

3/06/2019

Sample size

Target

120

Accrual to date

Final

130

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Rome

Funding & Sponsors

Funding source category [1]

University

Name [1]

Department of Maternal and Child Health Policlinico Umberto I, University La Sapienza, Rome, Italy

Address [1]

Viale del Policlinico, 155 , 00161 Roma RM

Country [1]

Italy

Primary sponsor type

University

Name

Department of Maternal and Child Health Policlinico Umberto I, University La Sapienza, Rome, Italy

Address

Viale del Policlinico, 155 , 00161 Roma RM

Country

Italy

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

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]

01/09/2018

Approval date [1]

13/09/2018

Ethics approval number [1]

5089

Summary

Brief summary

To assess the best energy intake for very low birth weight newborns, considering both possible benefits for growth and risk of metabolic complications, we designed a prospective study, comparing Cohort of newborns, which received Energy-Enhanced (Cohort A) vs. Standard (Cohort B) Parenteral Nutrition. The main outcome measure was the growth until 24 months of life. Extra-uterine growth retardation, complications associated with PN, survival, length of the hospital stay and morbidity at time point of 36 weeks of Post Menstrual Age were also measured.

Trial website

Trial related presentations / publications

Public notes

Since the 1st of January 2015, we prospectively collected, in a specific database, data regarding metabolic complications, nutritional intakes, morbidity, survival during hospitalization and growth until 24 months of life of all VLBW newborns consecutively observed in the NICU of Policlinico Umberto I. According with our policy, we collected and recorded only data of newborns for which parents gave informed signed consent. 
From the 1st of January 2015 to 31 January 2016, we used an aggressive PN protocol. Starting from the 1st of February 2016, we adopted a new PN protocol, consisting in a reduced energy intake.
To verify the effects of the change of nutritional policy on the children growth at 24 months of life, we designed a study protocol that was submitted to Ethical Committee. We obtained ethics approval in 13/09/2018.
Thus, in the first Cohort of the study we included newborns observed in the NICU from the 1st of January 2015 to 31 January 2016, and followed in paediatric office of NICU of Policlinico Umberto I for growth assessment until 31 January 2018 (i.e. historical Cohort).
In the second Cohort of the study, we included newborns admitted in the NICU from the 1st of February 2016 to 31 March 2017. On the 3rd June of 2019 we completed the follow-up of the last infant enrolled in the second Cohort of the study (namely “interventional Cohort”). Finally, we concluded the study and we analysed data prospectively collected in our database.

Contacts

Principal investigator

Name

Prof Gianluca Terrin

Address

Department of Maternal and Child Health 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 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 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

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
4626	Study protocol	gianluca.terrin@uniroma1.it	378327-(Uploaded-07-09-2019-21-40-04)-Study-related document.pdf
4627	Informed consent form	gianluca.terrin@uniroma1.it	378327-(Uploaded-07-09-2019-21-38-30)-Study-related document.pdf
4628	Statistical analysis plan	gianluca.terrin@uniroma1.it	378327-(Uploaded-07-09-2019-21-52-45)-Study-related document.pdf
4633	Ethical approval	gianluca.terrin@uniroma1.it	378327-(Uploaded-07-09-2019-21-36-30)-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

Source	Title	Year of Publication	DOI
Embase	Long-term effects on growth of an energy-enhanced parenteral nutrition in preterm newborn: A quasi-experimental study.	2020	https://dx.doi.org/10.1371/journal.pone.0235540

N.B. These documents automatically identified may not have been verified by the study sponsor.

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