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The effect of Dietary Protein Addition on nutritional status and clinical evolution in children and adolescents admitted to the Pediatric Intensive Care Unit

Effect of Protein Supplementation on nutritional status and clinical outcomes in Critically Ill Children on enteral nutritional therapy: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3h4x97
Enrollment
Unknown
Registered
2017-08-17
Start date
2016-09-19
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Intensive Care Unit, Critically ill, Respiratory insufficiency Respiration, Artificial, Protein Malnutrition

Interventions

Three groups will be evaluated: - Intervention group with protein 1: 25 children and adolescents admitted to Pediatric Intensive Care Unit will receive a polymeric protein module diluted in water and
Dietary supplement

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Hospital Infantil Joana de Gusmão
Collaborator

Eligibility

Age
1 Months to 14 Years

Inclusion criteria

Inclusion criteria: children of both sexes; aged 1 month to 14 years 11 months and 29 days of age; hospitalized for a maximum of 72 hours; with indication of enteral nutrition with polymeric diet.

Exclusion criteria

Exclusion criteria: discharge or death in the first 48 hours; inability to initiate enteral nutrition in the first 72 hours; use of parenteral nutrition; admission for moderate to severe burn; allergy to cow's milk protein or innate error metabolism; hepatic encephalopathy

Design outcomes

Primary

MeasureTime frame
Higher prevalence of patients with zero or positive nitrogen balance, evaluated by evaluating urine urea at 24 hours, after 5 days of intervention, in comparison to the control group

Secondary

MeasureTime frame
Lower incidence of mortality and nosocomial infection, assessed in percentual, in the intervention groups, compared to the control group, in the end of the study. Lower length of hospital and intensive care unit stay, and lower duration in mechanical ventilation, in the intervention groups, compared to the control group, in the end of the study. In the intervention groups, protein intake by enteral nutrition, after 5 days of intervention, of 1.5 to 3 g / kg / day. Maintenance in indicators of nutritional status, assessed by body mass index z-score for age, arm circumference for age, triceps skinfold for age, after 5 days of intervention.

Countries

Brazil

Contacts

Public ContactDaniela;Yara Maria Hauschild;Moreno

Universidade Federal de Santa Catarina;Universidade Federal de Santa Catarina

danielahauschild@yahoo.com.br;yarafmoreno@gmail.com+55 41 99996-2549;+55 48 37212215

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 24, 2026