Protein Supplementation vs Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Pilot RCT

NCT04565613 | Completed DMC

• 1 other identifier: 2020/2742
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial is part of a long-term research program leading to a large trial to determine if a strategy of supplementing protein in a subset of critically ill children is superior to standard enteral nutrition care. The investigators hypothesize that protein supplementation to critically ill children with body mass index (BMI) z-score \<0 reduces the length of stay in the paediatric intensive care unit (PICU) and hospital, as well as the duration of mechanical ventilation (MV).

Conditions

Critically Ill

Keywords

Critically ill; Protein supplementation; Nutrition

Outcome Measures

Primary Outcomes (4)

• Proportion of eligible patients approached for consent

  Number of eligible patients who are approached for consent

  Throughout study period, over 36 months

• Proportion of participants receiving their first protein supplementation within 72 hours of enrolment

  Number of patients who received protein supplementation within 72 hours of enrolment

  Throughout the study, over 24 months

• Participant accrual rate

  Average monthly enrolment at each centre

  Throughout the study, over 24 months

• Protocol adherence

  \>80% of protein target administered according to the protocol in the intervention arm

  Throughout study period, over 24 months

Secondary Outcomes (7)

• PICU mortality

  Throughout study period, over 36 months

• PICU length of stay

  Throughout study period, over 36 months

• Hospital length of stay

  Throughout the study period, over 36 months

• Adverse events

  Throughout study period, over 36 months

• Change in muscle size

  During PICU stay, PICU discharge, hospital discharge and 6 months follow-up

Study Arms (2)

Standard care group

NO INTERVENTION

The participants will receive feeding as per standard of care (without protein or any other supplementations).

Study interventional group

EXPERIMENTAL

The participants will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds.

Dietary Supplement: Enteral protein supplementation

Interventions

Enteral protein supplementation DIETARY_SUPPLEMENT

The participants in the study interventional group will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds. This will be via 100% whey protein isolate (Nestle Beneprotein). Doses will be calculated on the patient's admission weight and rounded up to the nearest 1g. Doses will not be adjusted to account for weight changes in the PICU. Protein supplementation will continue for a total of 7 days from the start of enrolment into the study or until PICU discharge, whichever is earlier. If the patient is able to take solid feeds during the study intervention period, the intervention will be stopped. However, if the device required for feeding is removed but the patient takes milk/liquid feeds fully, protein supplementation will continue.

Also known as: Protein isolate (Nestle Beneprotein)

Study interventional group

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between 28 days and 18 years of age
• Have a BMI z-score \< 0 on PICU admission
• Requires respiratory support in the form of invasive or non-invasive mechanical ventilation (CPAP or BiPAP) within 24-48 hours of PICU admission, and the attending physician expects the child to require any respiratory support for at least 48 hours of PICU admission
• Requires enteral nutrition support for feeding (e.g., oro-gastric, nasogastric, gastrostomy, naso-jejunal, oro-jejunal)
• Have an expected PICU stay of \> 48 hours

You may not qualify if:

• Are not expected to survive this PICU admission because of palliative care (e.g., do-not-resuscitate status) or limited life support
• Progressive neuromuscular disease (e.g., spinal muscular atrophy, Duchenne or other muscular dystrophy, multiple sclerosis, amyotrophic lateral sclerosis)
• Medical conditions where increased or decreased protein intake is required, including acute kidney injury (stage 3 KDIGO criteria), chronic kidney disease (stage 4 and 5), inborn errors of metabolism, fulminant liver failure, severe burn injury
• Contraindications to enteral nutrition (e.g., gut hemorrhage, post-gastrointestinal surgery etc.)
• Diagnosed cow's milk protein allergy
• Parenteral nutrition
• Premature infants who are less than corrected gestational age of 44 weeks (gestational age + weeks after birth)
• Were previously enrolled in this trial
• Are currently enrolled in a potentially confounding trial
• Diagnosis of anorexia nervosa and other eating disorders
• On extra-corporeal membrane oxygenation (ECMO) support
• Conditions that required significant fluid restriction (≤75% of maintenance fluid) (e.g., post cardiac surgery etc.)

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• Singapore Clinical Research Institute: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

Related Publications (1)

• Wong JJM, Ong JSM, Ong C, Allen JC, Gandhi M, Fan L, Taylor R, Lim JKB, Poh PF, Chiou FK, Lee JH. Protein supplementation versus standard feeds in underweight critically ill children: a pilot dual-centre randomised controlled trial protocol. BMJ Open. 2022 Jan 4;12(1):e047907. doi: 10.1136/bmjopen-2020-047907.

  PMID: 34983751 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Hau Lee

  KK Women's and Children's Hospital, SingHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Participants will be randomized to enteral protein supplementation or standard care (no enteral protein supplementation) in a 1:1 ratio.

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 25, 2020
• Study Start: January 25, 2021
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)