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

This study has been terminated.
(Reduced enrollment rate for SV patients due to high competition for studies)
Sponsor:
Information provided by (Responsible Party):
Ben Sivarajan, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00919945
First received: June 11, 2009
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Congenital Heart Disease
Other: Continuous feeding at time 1 and NPO at time 2
Other: NPO at time 1 and continuous feeding at time 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: Duration of patient's participation in the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: January 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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)
Experimental: 2
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
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).

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919945

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Ben Sivarajan, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Ben Sivarajan, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00919945     History of Changes
Other Study ID Numbers: 1000012584
Study First Received: June 11, 2009
Last Updated: May 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Neonates
Congenital Heart Disease
Postoperative Feeding
Splanchnic Blood Flow

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 21, 2014