Protein-Energy Malnutrition Clinical Trial
Official title:
Effect of the Administration of an Enteral Milk Supplemented With Proteins to Infants Admitted in a Pediatric Intensive Care Unit
A multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formula with different protein content. Blood and urine test, nitrogen balance assessment and energy expenditure testing by indirect calorimetry will be performed at the beginning of nutrition regimen and at 24 hours, 72 hours and 5-7 days after initiation. The sample size for this trial is estimated as 90 participants, with approximately 30 participants in each group. The data analysis will be by intention to treat. This RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, surrogate of protein balance, in critically ill infants receiving enteral nutrition.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 2 Years |
Eligibility |
Inclusion Criteria: 1. Children aged 1 month to 2 years. 2. Children admitted to PICU. 3. Children receiving enteral nutrition with an estimated length of over 72 hours. Exclusion Criteria: Children who met any of the following criteria will be excluded: 1. Age less than 1 month or over 2 years. 2. Diabetes mellitus or any inborn metabolic error. 3. Parenteral nutrition. 4. Bicarbonate infusion. 5. Renal replacement therapy. 6. Children receiving exclusive breastfeeding or in a need of special enteral formula. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Spain | Hospital Clínico Universitario de Santiago-CHUS | Santiago De Compostela | Galicia |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario Gregorio Marañon | European Regional Development Fund, Instituto de Salud Carlos III, Maternal, Neonatal and Child Health Research Network |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nitrogen balance variation | The variation of nitrogen balance (NB) from baseline to the study ending | From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days | |
Primary | Proportion of patients that meet study ending criteria | Study ending criteria: serum urea levels elevates higher than 80 mg/dL without evidence of renal function disturbance or hypercatabolism; hyperproteinemia higher than 8.5 g/dL . | From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days | |
Secondary | variation of plasma protein levels | variation of plasma protein levels (mg/dL) (total proteins, albumin, prealbumin, transferrin and retinol-binding protein) | From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days | |
Secondary | variation of resting energy expenditure | variation of resting energy expenditure measured with indirect calorimetry during the study period. | From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days | |
Secondary | the incidence of gastrointestinal complications | Gastrointestinal complications: abdominal distension, vomiting, diarrhea and excessive gastric residue | From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days |
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