Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs

NCT02973347 | Unknown DMC

• 1 other identifier: XH-16-039
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mechanical ventilation has become one of the most important supportive treatment methods to save the life of critically ill children over time. Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation. It is one of the leading causes of hospital-acquired infections in the Paediatric Intensive Care Unit (PICU).VAP can aggravate patients' condition and have adverse effect on mechanical ventilation. Moreover, VAP is associated with significant increased mortality. In those critical ill patients, the catabolism increased, the anabolism decreased, which can induce negative nitrogen balance. The consensus of optimal nutrition therapy in pediatric critical care in the Asia-Pacific, released in 2014, clearly recommended that early enteral nutrition support, which begin within 24-48 hours after admitting in PICU, can significantly reduce the prevalence and mortality of nosocomial infection. Intermittent enteral feeding and continual enteral feeding are the most common methods of enteral nutrition at present. There is no final conclusion about the association between enteral nutrition methods and VAP. Thus, the relationship between enteral feeding and VAP has long been a controversial issue. There is little clinical research on the correlation between enteral nutrition and VAP in children with mechanical ventilation, and mostly were observational studies which lacks strong evidence. How to choose the appropriate enteral nutrition remains an urgent need in PICU clinical work. Therefore, it is necessary for us to analyze the relationship between enteral feeding and VAP in critically ill children. This study would perform a two-year research with mechanical ventilated patients in PICU of four children hospitals in Shanghai, which aim to determine the relationship between different enteral feeding methods and VAP, to collect the baseline characteristic data of ventilated children, to analyze the risk factors for VAP in PICU patients. The results from our study would contribute to improving the standard of care for children undergoing mechanical ventilation, reducing their lung injury and improving prognosis.

Conditions

Enteral Feeding; Ventilator-Associated Pneumonia

Keywords

Enteral Feeding; Ventilator-Associated Pneumonia; Mechanical Ventilation; Pediatric Intensive Care Unit; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Ventilator-associated pneumonia

  The incidence of VAP in patients with intermittent enteral feeding strategy is compared with the incidence of VAP in patients with continuous enteral feeding strategy. Diagnosis of VAP as defined by national diagnostic criteria.

  at Day-28

Secondary Outcomes (4)

• Duration of ICU stay

  at Day-28

• Duration of hospital stay

  at Day-28

• ICU mortality

  at Day-28

• Hospital mortality

  at Day-28

Study Arms (2)

Intermittent enteral feeding

ACTIVE COMPARATOR

Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins.

Other: Intermittent enteral feeding

Continuous enteral feeding

ACTIVE COMPARATOR

Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours.

Other: Continuous enteral feeding

Interventions

Intermittent enteral feeding OTHER

The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins.

Intermittent enteral feeding

Continuous enteral feeding OTHER

The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.

Continuous enteral feeding

Eligibility Criteria

• Age: 29 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age of 29 days to 16 years.
• Subjects ventilated over or equal to 12 hours.
• Endotracheal intubation.
• Subjects without contraindication for enteral feeding.

You may not qualify if:

• Newborn or age \> or equal to 16 years.
• Subjects has been ventilated before this research.
• Subjects ventilated less than 12 hours.
• Invasive ventilation.
• Subjects with severe congenital malformations.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Children's Hospital of Fudan University: collaborator
• Shanghai Children's Hospital: collaborator
• Shanghai Children's Medical Center: collaborator

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Critical Illness

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaodong Zhu, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Yueniu Zhu, PhD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Yueniu Zhu, PhD

CONTACT

+86-21-25078999; zhuyueniu@hotmail.com

Lingxuezi Zhang, MD

CONTACT

+86-21-25078999; zlxz1989@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 25, 2016

Record last verified: 2016-11