NCT07801040

Brief Summary

This study aims to determine the differences in outcomes in groups with protein restriction in parenteral nutrition of critically ill infants, compared with protein regimens according to local guidelines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

August 28, 2026

Last Update Submit

September 2, 2026

Conditions

Critical IllnessParenteral Nutrition

Keywords

Critical ill neonatesNeonatal post-operative careProtein restriction

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Mortality

    Number of Deaths Occurring in the First 7 Days Post-Randomization

    7 days after diagnosed as critically ill

Secondary Outcomes (1)

  • Duration of the Acute Phase Critically Ill Neonates

    72 to 96 hours

Study Arms (2)

Protrein restriction

EXPERIMENTAL

Reduced to 1.2 gram/kg/day

Dietary Supplement: Amino acid infusion

No protein restriction

NO INTERVENTION

\>2 gram/kg/day or according to previous dose

Interventions

Amino acid infusionDIETARY_SUPPLEMENT

Protein: reduced to 1.2 gram/kg/day

Protrein restriction

Eligibility Criteria

Age72 Hours - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • postmenstrual age \>32 weeks old
  • actual weight \>1.500 gram

You may not qualify if:

  • given \<1 gram/kg/day of protein
  • critical congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ciptomangunkusumo Public Hospital

Jakarta Pusat, DKI Jakarta, 12810, Indonesia

Location

MeSH Terms

Conditions

Critical IllnessHyperphagia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Neonatologist, Neonatology Division, Department of Child Health, Faculty of Medicine Universitas Indonesia

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 3, 2026

Study Start

October 17, 2025

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations

ID(1)