Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657629
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Nicole Spillane, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Hypoplastic Left Heart Syndrome
Growth Failure
Interventions Other: Continuous Feeding Regimen
Other: Intermittent Bolus Feeding Regimen
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Feeding Regimen Intermittent Bolus Feeding Regimen
Hide Arm/Group Description

Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.

Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Enteral feedings given as intermittent bolus feedings for entire 24 hour period.

Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Period Title: Overall Study
Started 14 14
Completed 12 14
Not Completed 2 0
Arm/Group Title Continuous Feeding Regimen Intermittent Bolus Feeding Regimen Total
Hide Arm/Group Description

Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.

Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Enteral feedings given as intermittent bolus feedings for entire 24 hour period.

Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Total of all reporting groups
Overall Number of Baseline Participants 12 14 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
<=18 years
12
 100.0%
14
 100.0%
26
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Gestational age in weeks at birth
Number Analyzed 12 participants 14 participants 26 participants
38.3  (1) 38.9  (1.5) 38.6  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
Female
5
  41.7%
2
  14.3%
7
  26.9%
Male
7
  58.3%
12
  85.7%
19
  73.1%
1.Primary Outcome
Title Weight Gain in Grams Per Day
Hide Description [Not Specified]
Time Frame Daily until hospital discharge (up to maximum of 3 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Feeding Regimen Intermittent Bolus Feeding Regimen
Hide Arm/Group Description:

Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.

Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Enteral feedings given as intermittent bolus feedings for entire 24 hour period.

Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: grams/day
24.3  (14.6) 23.6  (7.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Feeding Regimen, Intermittent Bolus Feeding Regimen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Feeding Regimen Intermittent Bolus Feeding Regimen
Hide Arm/Group Description

Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.

Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

Enteral feedings given as intermittent bolus feedings for entire 24 hour period.

Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.

All-Cause Mortality
Continuous Feeding Regimen Intermittent Bolus Feeding Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Continuous Feeding Regimen Intermittent Bolus Feeding Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      2/14 (14.29%)    
Gastrointestinal disorders     
necrotizing enterocolitis   0/12 (0.00%)  0 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders     
aspiration  1/12 (8.33%)  1 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Feeding Regimen Intermittent Bolus Feeding Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/14 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicole Spillane MD
Organization: HackensackUMC
Phone: 917-446-6656
EMail: nspillane@hackensackumc.org
Layout table for additonal information
Responsible Party: Nicole Spillane, Columbia University
ClinicalTrials.gov Identifier: NCT02657629    
Other Study ID Numbers: AAAE0781
First Submitted: January 14, 2016
First Posted: January 18, 2016
Results First Submitted: January 19, 2016
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016