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

Primary Purpose

Congenital Heart Disease

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Continuous feeding at time 1 and NPO at time 2
NPO at time 1 and continuous feeding at time 2
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Neonates, Congenital Heart Disease, Postoperative Feeding, Splanchnic Blood Flow

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
June 11, 2009
Last Updated
May 12, 2014
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00919945
Brief Title
Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn
Official Title
Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Reduced enrollment rate for SV patients due to high competition for studies
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Neonates with critical congenital heart disease (CHD) undergoing surgery often have postoperative decreases in cardiac output. These hemodynamic changes can result in varying levels of organ dysfunction, ranging from the subclinical to the more overt. Although this low cardiac output syndrome (LCOS) and accompanying multiorgan dysfunction syndrome (MODS) is in large part transient, the rapidity and completeness of resolution can vary greatly. During postoperative care in the intensive care unit, knowledge of this phenomenon must be balanced against the desire to initiate enteral nutrition. Many studies have demonstrated that timely initiation of enteral feeds in the intensive care can reduce mortality, morbidity and costs. Practically speaking, the decision to initiate feeds is made based on the patient's postoperative hemodynamic status, a normal lactate, absence of vasopressor agents and presence of bowel sounds. Trophic enteral feeding can usually commence 24h postoperatively, even after complicated neonatal heart surgery, The vast majority of postoperative neonates suffer no apparent ill effects from this management strategy. However, recent data have demonstrated an exceedingly high incidence (3.3-6.8%) of necrotizing enterocolitis (NEC) in CHD patients; a disease for which diminution in splanchnic blood flow and disruption of the mucosal barrier are felt to play an important role. These data suggest the combination of diminished cardiovascular reserve, cyanosis and increased myocardial oxygen demands may promote the development of NEC. Preliminary data from Sickkids (Chanthong and Sivarajan, 2008) demonstrates an NEC incidence of 8% in CHD patients. Patients with NEC also accounted for 25% of all cardiac arrests in Cardiac CCU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Neonates, Congenital Heart Disease, Postoperative Feeding, Splanchnic Blood Flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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).
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Continuous feeding at time 1 and NPO at time 2
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
NPO at time 1 and continuous feeding at time 2
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in ultrasound derived bloodflow in superior mesenteric artery after feeding by 1 SD from prefeeding value.
Time Frame
At 0, 6, 12 and 24 hours after arrival at CCU; At 12 and 24 hours after decision to feed is made
Secondary Outcome Measure Information:
Title
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
Time Frame
Duration of patient's participation in the study
Title
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
Time Frame
Duration of patient's participation in the study
Title
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
Time Frame
Duration of patient's [articipation in the study

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Sivarajan, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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

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