Supplemental Parenteral Nutrition in Pediatric Respiratory Failure

NCT ID: NCT01937884

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-08-31

Brief Summary

Optimal delivery of nutritional support during critical illness is central to appropriate intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing, route, dose, and type of nutritional support for critically ill infants and children. Understanding how to optimize nutritional support during pediatric critical illness is important because even brief periods of malnutrition in infancy result in permanent negative effects on long-term neurocognitive development. Optimized nutrition support is a way to improve morbidity for survivors of pediatric critical illness. Parenteral nutrition (PN) supplementation could improve long-term neurocognitive outcome for pediatric critical illness by preventing acute malnutrition, but has unknown effects on intestinal barrier function; a proposed mechanism for late sepsis and infectious complications during critical illness.

While randomized controlled trials (RCT) support early PN in premature infants and late PN in critically ill adults, the optimal time to begin PN is unknown for critically ill infants and children. Acute malnutrition may develop within 48 hours of admission in critically ill infants and children, and repleted energy stores are predictive of survival. And yet, due to concerns for PN-associated infectious morbidity, current PICU standard of care is to supplement with PN only in children who fail to enterally feed, as late as 7 days into their admission. Delays in nutrition may have long-term effects on cognitive outcome in older infants and children. In premature infants, PN begun within hours of birth results in improved 18-month neurocognitive outcome without an increase in infectious complications. An RCT is needed to determine if early PN in critically ill infants and children prevents acute malnutrition and improves short and long-term outcomes of PICU hospitalization.

The central hypothesis of this proposal is that optimized early protein and calorie delivery will improve nutritional outcomes and intestinal barrier function for critically ill infants and children. The overall purpose of this study is to evaluate the efficacy and safety of early PN as a supplement to enteral nutrition to improve nutritional delivery, nutritional outcomes, and intestinal barrier function for infants and children with acute respiratory failure who are mechanically ventilated in the pediatric intensive care unit.

Conditions

Acute Respiratory Failure With Hypoxia; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Parenteral Nutrition

Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.

Group Type: EXPERIMENTAL

Parenteral Nutrition

Intervention Type: DRUG

Late Parenteral Nutrition

Patients receive supplemental parenteral nutrition 96 hours after enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.

Group Type: ACTIVE_COMPARATOR

Parenteral Nutrition

Intervention Type: DRUG

Interventions

Parenteral Nutrition

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Admitted to study hospital pediatric intensive care unit (PICU),

2. One month to 16 years of age,

3. Exhibits Acute Hypoxemic Respiratory Failure as defined as: PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 260, No evidence of cardiac dysfunction, Mechanically ventilated,

4. Require artificial nutrition,

5. Anticipate placement of central venous line within 24 hours of admission

Exclusion Criteria

1. Premature infants and neonates < 37 weeks corrected gestational age,

2. Transfer patient on an established enteral or parenteral nutritional regimen,

3. Known allergy to lactulose or mannitol,

4. Pregnant,

5. Admit BMI >30,

6. Thoracic trauma, abdominal trauma, and/or active intracranial bleeding,

7. Anuric renal failure, previous bowel surgery and/or short gut syndrome,

8. Cannot be enterally fed within 24 hours of admission according to the admitting physician,

9. On extracorporeal membrane oxygenation (ECMO),

10. Expected survival <24 hours or limitations to aggressive ICU care (DNR),

11. Receiving active CPR when admitted to the PICU,

12. A pre-existing bronchopleural fistula,

13. Previously enrolled and randomized into this protocol,

14. Actively enrolled in another clinical trial which at the discretion of the PI would conflict with this study.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Katri Typpo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katri V Typpo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona Medical Center

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5K12HD047349-09

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-0374

Identifier Type: -

Identifier Source: org_study_id