Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn

NCT00919945 | Terminated Phase 2 DMC

• 1 other identifier: 1000012584
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the impact of early post-operative feeding on splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall clinical outcomes.

Conditions

Congenital Heart Disease

Keywords

Neonates; Congenital Heart Disease; Postoperative Feeding; Splanchnic Blood Flow

Outcome Measures

Primary Outcomes (1)

• Change in ultrasound derived bloodflow in superior mesenteric artery after feeding by 1 SD from prefeeding value.

  At 0, 6, 12 and 24 hours after arrival at CCU; At 12 and 24 hours after decision to feed is made

Secondary Outcomes (3)

• Impact of Feeding on: Cardiac Output as measured by continuous mass spectometry, Fractional splanchnic output, Renal Perfusion, Tonometric, Assessment of gastric mucosal pH e. Cerebral oxygen delivery using the NIRS probe

  Duration of patient's participation in the study

• Correlation and Agreement between: Echo and continuous cardiac output measures; gastric tonometry, SMA PSV and qualitative Bowel Perfusion Index; renal artery PSV and temporal urine output

  Duration of patient's participation in the study

• Patient Outcomes: Survival, Time to Extubation, Duration of Postop ICU Admission, Duration of Postop hospital Admission, Discharge weight, Number of Nosocomial Infections, Development of NEC

  Duration of patient's [articipation in the study

Study Arms (2)

1

EXPERIMENTAL

The initial observation period of the study begins in the postoperative period (time 0) after the patient arrives in the Cardiac Critical Care Unit and calibration of the monitors with initial clinically indicated baseline bloodwork is completed. Eligible patients will be randomized when the clinical decision to feed is made (by the treating team) to one of the two treatment arms. Patients in arm 1 will receive continuous nasogastric formula feeding at time 1 and NPO at time 2 (12 hours later).

Other: Continuous feeding at time 1 and NPO at time 2

2

EXPERIMENTAL

The initial observation period of the study begins in the postoperative period (time 0) after the patient arrives in the Cardiac Critical Care Unit and calibration of the monitors with initial clinically indicated baseline bloodwork is completed. Eligible patients will be randomized when the clinical decision to feed is made (by the treating team) to one of the two treatment arms. Patients in arm 2 will receive NPO at time 1 and crossover to continuous nasogastric formula feeding at time 2.

Other: NPO at time 1 and continuous feeding at time 2

Interventions

Continuous feeding at time 1 and NPO at time 2 OTHER

Continuous nasogastric formula feeding (using Enfalac with iron 2400 kJ/L at a volume of 1ml/kg/h) at time 1 and NPO at time 2 (12 hours later)

1

NPO at time 1 and continuous feeding at time 2 OTHER

NPO at time 1 and continuous nasogastric formula feeding (using Enfalac with iron 2400 kJ/L at a volume of 1ml/kg/h) at time 2 (12 hours later).

2

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• neonates ≤ 30 days of postnatal age at time of operation
• birthweight \> 2.5 kg
• gestational age at birth ≥ 35 weeks
• Patients requiring cardiac surgery who are expected to remain intubated in the CCIU for \> 48 hours
• informed consent by parent or guardian
• approval by treating critical care staff physician

You may not qualify if:

• patients with heterotaxy or pre-existing renal or abdominal pathology (eg. preoperative diagnosis of NEC).
• need for ECMO after repair within the study period (data up to that point will be recorded and analyzed).
• Parent refusal of formula for purposes of study
• Patient on vasopressin or norepinephrine infusion
• Parent or legal guardian refuse consent

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ben Sivarajan, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (1)