Hypoplastic Left Heart SyndromeNCT02657629
Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
A study testing Continuous Feeding Regimen and Intermittent Bolus Feeding Regimen in people with Hypoplastic Left Heart Syndrome and Growth Failure, run by Columbia University.
Trial summary
The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1 procedures. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Hypoplastic Left Heart Syndrome, Growth Failure
- What is being tested?
- Continuous Feeding Regimen and Intermittent Bolus Feeding Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with HLHS/SVV who underwent stage 1 procedures (Norwood or Hybrid procedure) who were inborn or transferred into the Neonatal Intensive Care Unit at Columbia University Medical Center
Who cannot join
- Excluded subjects were those with associated major congenital malformations (e.g. congenital diaphragmatic hernia, gastroschisis) or chromosomal anomalies, and/or those who were small for gestational age at birth.
- Subjects in whom a nasogastric tube or gastrostomy tube was not required for feeding at the time of enrollment and/or who were transferred to outside institutions for recovery after surgery.
About this study
Official title: Comparison of Feeding Strategies After Stage 1 Procedures for Hypoplastic Left Heart Syndrome Infants: A Randomized Controlled Trial
The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1 procedures.
Read the detailed description
In recent years, survival after neonatal cardiac surgery has improved significantly. As life span has improved in HLHS/single ventricle variants (SVV) survivors, focus has shifted to the understanding and management of associated health problems. Growth failure is a well-recognized major co-morbidity in these patients.
Infants with HLHS/SVV demonstrate progressive growth failure after stage 1 procedures, which appears to stabilize only after stage 2 procedures. Poor nutritional status increases risk for post-operative infections, extends hospital length-of-stay, and adversely affects neurodevelopmental outcomes.
To date, evidence-based feeding strategies that support adequate weight gain and improve nutritional status have not been identified after stage 1 procedures. Continuous enteral feeding regimens have resulted in improved growth in a diverse population of infants with congenital heart disease and have been shown to decrease energy expenditure in premature infants and adults. A randomized, controlled study of HLHS/SVV infants who underwent stage 1 procedures at a single medical center was conducted with the primary objective of comparing weight gain at hospital discharge between infants receiving a continuous feeding regimen versus an intermittent feeding regimen. Secondary objectives were to compare growth and markers of nutritional status at hospital discharge between the two groups. The investigators hypothesized that infants with HLHS/SVV who receive a continuous enteral feeding regimen versus an intermittent feeding regimen will demonstrate improved weight gain, growth, and nutritional status after stage 1 procedures at hospital discharge.
- Conditions
- Hypoplastic Left Heart Syndrome, Growth Failure
- Being tested
- Continuous Feeding Regimen, Intermittent Bolus Feeding Regimen
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Feeding RegimenOther
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.
Intermittent Bolus Feeding RegimenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Feeding Regimen | Active comparator | Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings. Receives: Other: Continuous Feeding Regimen |
| Intermittent Bolus Feeding Regimen | Active comparator | Enteral feedings given as intermittent bolus feedings for entire 24 hour period. Receives: Other: Intermittent Bolus Feeding Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain in Grams Per Day
Measured: Daily until hospital discharge (up to maximum of 3 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startDec 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Spillane, Columbia University
- Investigators
- Ganga Krishnamurthy, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657629
- Sponsor's protocol ID
- AAAE0781
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 15 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Slicker J, Hehir DA, Horsley M, Monczka J, Stern KW, Roman B, Ocampo EC, Flanagan L, Keenan E, Lambert LM, Davis D, Lamonica M, Rollison N, Heydarian H, Anderson JB; Feeding Work Group of the National Pediatric Cardiology Quality Improvement Collaborative. Nutrition algorithms for infants with hypoplastic left heart syndrome; birth through the first interstage period. Congenit Heart Dis. 2013 Mar-Apr;8(2):89-102. doi: 10.1111/j.1747-0803.2012.00705.x. Epub 2012 Aug 14.
PubMed 22891735Wolovits JS, Torzone A. Feeding and nutritional challenges in infants with single ventricle physiology. Curr Opin Pediatr. 2012 Jun;24(3):295-300. doi: 10.1097/MOP.0b013e32835356ae.
PubMed 22572758Grant J, Denne SC. Effect of intermittent versus continuous enteral feeding on energy expenditure in premature infants. J Pediatr. 1991 Jun;118(6):928-32. doi: 10.1016/s0022-3476(05)82213-9.
PubMed 1904091Heymsfield SB, Casper K, Grossman GD. Bioenergetic and metabolic response to continuous v intermittent nasoenteric feeding. Metabolism. 1987 Jun;36(6):570-5. doi: 10.1016/0026-0495(87)90169-7.
PubMed 3108622Ravishankar C, Zak V, Williams IA, Bellinger DC, Gaynor JW, Ghanayem NS, Krawczeski CD, Licht DJ, Mahony L, Newburger JW, Pemberton VL, Williams RV, Sananes R, Cook AL, Atz T, Khaikin S, Hsu DT; Pediatric Heart Network Investigators. Association of impaired linear growth and worse neurodevelopmental outcome in infants with single ventricle physiology: a report from the pediatric heart network infant single ventricle trial. J Pediatr. 2013 Feb;162(2):250-6.e2. doi: 10.1016/j.jpeds.2012.07.048. Epub 2012 Aug 30.
PubMed 22939929Hehir DA, Cooper DS, Walters EM, Ghanayem NS. Feeding, growth, nutrition, and optimal interstage surveillance for infants with hypoplastic left heart syndrome. Cardiol Young. 2011 Dec;21 Suppl 2:59-64. doi: 10.1017/S1047951111001600.
PubMed 22152530
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Feeding Strategies After Stage 1 Procedures for Hypoplastic Left Heart Syndrome Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02657629
- Acronym / sponsor ID
- AAAE0781
- Conditions
- Hypoplastic Left Heart Syndrome, Growth Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1 procedures.
Detailed description
In recent years, survival after neonatal cardiac surgery has improved significantly. As life span has improved in HLHS/single ventricle variants (SVV) survivors, focus has shifted to the understanding and management of associated health problems. Growth failure is a well-recognized major co-morbidity in these patients.
Infants with HLHS/SVV demonstrate progressive growth failure after stage 1 procedures, which appears to stabilize only after stage 2 procedures. Poor nutritional status increases risk for post-operative infections, extends hospital length-of-stay, and adversely affects neurodevelopmental outcomes.
To date, evidence-based feeding strategies that support adequate weight gain and improve nutritional status have not been identified after stage 1 procedures. Continuous enteral feeding regimens have resulted in improved growth in a diverse population of infants with congenital heart disease and have been shown to decrease energy expenditure in premature infants and adults. A randomized, controlled study of HLHS/SVV infants who underwent stage 1 procedures at a single medical center was conducted with the primary objective of comparing weight gain at hospital discharge between infants receiving a continuous feeding regimen versus an intermittent feeding regimen. Secondary objectives were to compare growth and markers of nutritional status at hospital discharge between the two groups. The investigators hypothesized that infants with HLHS/SVV who receive a continuous enteral feeding regimen versus an intermittent feeding regimen will demonstrate improved weight gain, growth, and nutritional status after stage 1 procedures at hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Feeding Regimen | Active comparator | Other: Continuous Feeding RegimenEnteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings. |
| Intermittent Bolus Feeding Regimen | Active comparator | Other: Intermittent Bolus Feeding RegimenEnteral feedings given as intermittent bolus feedings for entire 24 hour period. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects with HLHS/SVV who underwent stage 1 procedures (Norwood or Hybrid procedure) who were inborn or transferred into the Neonatal Intensive Care Unit at Columbia University Medical Center
Key exclusion criteria (2 listed)
- Excluded subjects were those with associated major congenital malformations (e.g. congenital diaphragmatic hernia, gastroschisis) or chromosomal anomalies, and/or those who were small for gestational age at birth.
- Subjects in whom a nasogastric tube or gastrostomy tube was not required for feeding at the time of enrollment and/or who were transferred to outside institutions for recovery after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Feeding RegimenNocturnal 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. | Other | Continuous Feeding Regimen |
| Intermittent Bolus Feeding RegimenIntermittent 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. | Other | Intermittent Bolus Feeding Regimen |
Primary outcome
Weight Gain in Grams Per Day
Time frame: Daily until hospital discharge (up to maximum of 3 months of age)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22891735Slicker J, Hehir DA, Horsley M, Monczka J, Stern KW, Roman B, Ocampo EC, Flanagan L, Keenan E, Lambert LM, Davis D, Lamonica M, Rollison N, Heydarian H, Anderson JB; Feeding Work Group of the National Pediatric Cardiology Quality Improvement Collaborative. Nutrition algorithms for infants with hypoplastic left heart syndrome; birth through the first interstage period. Congenit Heart Dis. 2013 Mar-Apr;8(2):89-102. doi: 10.1111/j.1747-0803.2012.00705.x. Epub 2012 Aug 14.
- Results publication: PubMed 22572758Wolovits JS, Torzone A. Feeding and nutritional challenges in infants with single ventricle physiology. Curr Opin Pediatr. 2012 Jun;24(3):295-300. doi: 10.1097/MOP.0b013e32835356ae.
- Results publication: PubMed 1904091Grant J, Denne SC. Effect of intermittent versus continuous enteral feeding on energy expenditure in premature infants. J Pediatr. 1991 Jun;118(6):928-32. doi: 10.1016/s0022-3476(05)82213-9.
- Results publication: PubMed 3108622Heymsfield SB, Casper K, Grossman GD. Bioenergetic and metabolic response to continuous v intermittent nasoenteric feeding. Metabolism. 1987 Jun;36(6):570-5. doi: 10.1016/0026-0495(87)90169-7.
- Results publication: PubMed 22939929Ravishankar C, Zak V, Williams IA, Bellinger DC, Gaynor JW, Ghanayem NS, Krawczeski CD, Licht DJ, Mahony L, Newburger JW, Pemberton VL, Williams RV, Sananes R, Cook AL, Atz T, Khaikin S, Hsu DT; Pediatric Heart Network Investigators. Association of impaired linear growth and worse neurodevelopmental outcome in infants with single ventricle physiology: a report from the pediatric heart network infant single ventricle trial. J Pediatr. 2013 Feb;162(2):250-6.e2. doi: 10.1016/j.jpeds.2012.07.048. Epub 2012 Aug 30.
- Results publication: PubMed 22152530Hehir DA, Cooper DS, Walters EM, Ghanayem NS. Feeding, growth, nutrition, and optimal interstage surveillance for infants with hypoplastic left heart syndrome. Cardiol Young. 2011 Dec;21 Suppl 2:59-64. doi: 10.1017/S1047951111001600.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganga Krishnamurthy, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Feeding Regimen and Intermittent Bolus Feeding Regimen in people with Hypoplastic Left Heart Syndrome and Growth Failure, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Gain in Grams Per Day (time frame: Daily until hospital discharge (up to maximum of 3 months of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657629, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.