Congenital Heart DefectsNCT01475357
Intestinal Function in Neonates With Complex Congenital Heart Disease
A study testing Arm 1: NPO by mouth pre-operative and Arm 2: Fresh Breast Milk pre-operative in people with Congenital Heart Defects and Growth Failure, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and… Read more about this study
- Who is it for?
- Ages 37 to 40 weeks
- Conditions the study is for
- Congenital Heart Defects, Growth Failure
- What is being tested?
- Arm 1: NPO by mouth pre-operative and Arm 2: Fresh Breast Milk pre-operative
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 37 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study subjects will be male and female neonates admitted to MUSC PCICU or NICU prior to 72 hours of life who are gestational age ≥ 37 weeks.
- inpatient status at MUSC for a minimum of 48 hours prior to planned surgery and have a postnatal diagnosis of complex congenital heart disease - defined as a structural heart defect requiring cardiac surgery (reparative or palliative) prior to hospital discharge.
Who cannot join
- Infants with hemodynamic instability in the pre-operative period requiring mechanical circulatory support or
- who have the presence of lactate > 3 after the first 24 hours of admission
- admission from home
- major congenital extracardiac abnormalities (i.e. renal, brain, GI)
- cardiac surgery will not be performed at MUSC, and
- mother does not plan to pump breastmilk during the infant's first week of life.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk feeds in the pre-operative period will show improved gut function than neonates who were strictly NPO (nothing by mouth) in the pre-operative period.
Read the detailed description
The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The foundational hypothesis of this proposal is that term neonates (≥ 37 weeks gestation) with complex congenital heart disease (CHD) are vulnerable to disturbances in intestinal mucosal function, permeability, microflora, and local immune function, which ultimately result in feeding intolerance and poor somatic growth. By identifying biologic targets for perioperative intestinal protection, this project has the potential to shift and improve the paradigm of perioperative care for neonates with complex CHD. This pilot study will generate the data necessary to pursue K23 and R01 funding to further investigate postnatal intestinal maturation and function in neonates with complex CHD and cyanosis, specifically as it pertains to local immune function and inflammatory response.
The objectives of this proposal are to perform a single-center (MUSC), prospective, randomized pilot trial to investigate postnatal intestinal function in cardiac infants through the following Specific Aims:
Specific Aim 1: To compare the decrease in intestinal permeability as determined by urine lactulose: mannitol ratios of the trophic breastmilk fed group (intervention) vs. NPO (nothing by mouth) group (current care) amongst neonates with complex CHD over 3 different time points (postnatal day 3-4, post-operative day 7-8, and post-operative day 13-14).
H1: Infants who receive trophic breastmilk feeds in the pre-operative period will demonstrate a more rapid decrease in intestinal permeability (improved postnatal intestinal maturation) over the first 2 weeks of life compared to those infants who were strictly NPO in the pre-operative period.
Specific Aim 2: To compare the duration (in days) until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs. NPO group.
H1: Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period.
Specific Aim 3: To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs. NPO group.
H1: The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period.
- Conditions
- Congenital Heart Defects, Growth Failure
- Being tested
- Arm 1: NPO by mouth pre-operative, Arm 2: Fresh Breast Milk pre-operative
- Keywords
- congenital heart defects, growth failure
- Medical subject headings
- Heart Defects, Congenital, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: NPO by mouth pre-operativeOther
Current treatment for infants born with cardiac defects awaiting surgery is to keep them NPO pre-operatively. Arm 1 will make no changes to this current policy.
Arm 2: Fresh Breast Milk pre-operativeOther
Infants randomized to Arm 2 of the study will receive their mother's own breast milk pre-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: NPO pre-operative | Other | 1) Current care - NPO (nothing by mouth) postnatal intestinal function of neonates with complex CHD who receive enteral trophic breastmilk (10cc/kg/day) feeds (intervention) vs NPO (nothing by mouth) in the pre-operative period. Receives: Other: Arm 1: NPO by mouth pre-operative |
| Arm 2: Fresh Breast Milk pre-operative | Active comparator | 2) Intervention - Trophic mother's own fresh (non-frozen) breastmilk gavage feeds via nasogastric tube every 3 hours at 10 cc/kg/day Receives: Other: Arm 2: Fresh Breast Milk pre-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine lactulose/mannitol ratio over time
Specific Aim 1: compare decrease in intestinal permeability by urine lactulose: mannitol ratios of the trophic breastmilk fed group (intervention) vs. NPO (nothing by mouth) group (current care) amongst neonates with complex CHD over 3 different time points (postnatal day 3-4, post-operative day 7-8, and post-operative day 13-14).
Measured: post-natal day 3-4 (baseline), post-op days 7 and 14
Secondary outcomes (2)
Enteral Feeds
Specific Aim 2: To compare the duration (in days) until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs. NPO group.
H1: Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period.
Measured: Duration (in days) until goal enteral feeds are achieved, an expected average of 3 weeks
Intestinal Microflora Pattern
Specific Aim 3: To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs. NPO group.
H1: The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period.
Measured: 30 days 1st post-partum month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinai Zyblewski, Medical University of South Carolina
- Investigators
- Sinai C Zyblewski, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475357
- Sponsor's protocol ID
- HR 20394
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson JB, Beekman RH 3rd, Border WL, Kalkwarf HJ, Khoury PR, Uzark K, Eghtesady P, Marino BS. Lower weight-for-age z score adversely affects hospital length of stay after the bidirectional Glenn procedure in 100 infants with a single ventricle. J Thorac Cardiovasc Surg. 2009 Aug;138(2):397-404.e1. doi: 10.1016/j.jtcvs.2009.02.033. Epub 2009 May 23.
PubMed 19619784Kelleher DK, Laussen P, Teixeira-Pinto A, Duggan C. Growth and correlates of nutritional status among infants with hypoplastic left heart syndrome (HLHS) after stage 1 Norwood procedure. Nutrition. 2006 Mar;22(3):237-44. doi: 10.1016/j.nut.2005.06.008.
PubMed 16500550MEHRIZI A, DRASH A. Growth disturbance in congenital heart disease. J Pediatr. 1962 Sep;61:418-29. doi: 10.1016/s0022-3476(62)80373-4. No abstract available.
PubMed 14472142Owens JL, Musa N. Nutrition support after neonatal cardiac surgery. Nutr Clin Pract. 2009 Apr-May;24(2):242-9. doi: 10.1177/0884533609332086.
PubMed 19321898Schwalbe-Terilli CR, Hartman DH, Nagle ML, Gallagher PR, Ittenbach RF, Burnham NB, Gaynor JW, Ravishankar C. Enteral feeding and caloric intake in neonates after cardiac surgery. Am J Crit Care. 2009 Jan;18(1):52-7. doi: 10.4037/ajcc2009405.
PubMed 19116405Jeffries HE, Wells WJ, Starnes VA, Wetzel RC, Moromisato DY. Gastrointestinal morbidity after Norwood palliation for hypoplastic left heart syndrome. Ann Thorac Surg. 2006 Mar;81(3):982-7. doi: 10.1016/j.athoracsur.2005.09.001.
PubMed 16488706Pickard SS, Feinstein JA, Popat RA, Huang L, Dutta S. Short- and long-term outcomes of necrotizing enterocolitis in infants with congenital heart disease. Pediatrics. 2009 May;123(5):e901-6. doi: 10.1542/peds.2008-3216.
PubMed 19403484del Castillo SL, Moromisato DY, Dorey F, Ludwick J, Starnes VA, Wells WJ, Jeffries HE, Wong PC. Mesenteric blood flow velocities in the newborn with single-ventricle physiology: modified Blalock-Taussig shunt versus right ventricle-pulmonary artery conduit. Pediatr Crit Care Med. 2006 Mar;7(2):132-7. doi: 10.1097/01.PCC.0000200999.89777.92.
PubMed 16474253Harrison AM, Davis S, Reid JR, Morrison SC, Arrigain S, Connor JT, Temple ME. Neonates with hypoplastic left heart syndrome have ultrasound evidence of abnormal superior mesenteric artery perfusion before and after modified Norwood procedure. Pediatr Crit Care Med. 2005 Jul;6(4):445-7. doi: 10.1097/01.PCC.0000163674.53466.CA.
PubMed 15982432McElhinney DB, Hedrick HL, Bush DM, Pereira GR, Stafford PW, Gaynor JW, Spray TL, Wernovsky G. Necrotizing enterocolitis in neonates with congenital heart disease: risk factors and outcomes. Pediatrics. 2000 Nov;106(5):1080-7. doi: 10.1542/peds.106.5.1080.
PubMed 11061778Bernstein D, Bell JG, Kwong L, Castillo RO. Alterations in postnatal intestinal function during chronic hypoxemia. Pediatr Res. 1992 Mar;31(3):234-8. doi: 10.1203/00006450-199203000-00008.
PubMed 1561008Willis L, Thureen P, Kaufman J, Wymore E, Skillman H, da Cruz E. Enteral feeding in prostaglandin-dependent neonates: is it a safe practice? J Pediatr. 2008 Dec;153(6):867-9. doi: 10.1016/j.jpeds.2008.04.074.
PubMed 19014824Braudis NJ, Curley MA, Beaupre K, Thomas KC, Hardiman G, Laussen P, Gauvreau K, Thiagarajan RR. Enteral feeding algorithm for infants with hypoplastic left heart syndrome poststage I palliation. Pediatr Crit Care Med. 2009 Jul;10(4):460-6. doi: 10.1097/PCC.0b013e318198b167.
PubMed 19307819del Castillo SL, McCulley ME, Khemani RG, Jeffries HE, Thomas DW, Peregrine J, Wells WJ, Starnes VA, Moromisato DY. Reducing the incidence of necrotizing enterocolitis in neonates with hypoplastic left heart syndrome with the introduction of an enteral feed protocol. Pediatr Crit Care Med. 2010 May;11(3):373-7. doi: 10.1097/PCC.0b013e3181c01475.
PubMed 19838139Natarajan G, Reddy Anne S, Aggarwal S. Enteral feeding of neonates with congenital heart disease. Neonatology. 2010;98(4):330-6. doi: 10.1159/000285706. Epub 2010 May 7.
PubMed 20453528
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Function in Neonates With Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01475357
- Acronym / sponsor ID
- HR 20394
- Conditions
- Congenital Heart Defects, Growth Failure
- Keywords
- congenital heart defects, growth failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk feeds in the pre-operative period will show improved gut function than neonates who were strictly NPO (nothing by mouth) in the pre-operative period.
Detailed description
The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The foundational hypothesis of this proposal is that term neonates (≥ 37 weeks gestation) with complex congenital heart disease (CHD) are vulnerable to disturbances in intestinal mucosal function, permeability, microflora, and local immune function, which ultimately result in feeding intolerance and poor somatic growth. By identifying biologic targets for perioperative intestinal protection, this project has the potential to shift and improve the paradigm of perioperative care for neonates with complex CHD. This pilot study will generate the data necessary to pursue K23 and R01 funding to further investigate postnatal intestinal maturation and function in neonates with complex CHD and cyanosis, specifically as it pertains to local immune function and inflammatory response.
The objectives of this proposal are to perform a single-center (MUSC), prospective, randomized pilot trial to investigate postnatal intestinal function in cardiac infants through the following Specific Aims:
Specific Aim 1: To compare the decrease in intestinal permeability as determined by urine lactulose: mannitol ratios of the trophic breastmilk fed group (intervention) vs. NPO (nothing by mouth) group (current care) amongst neonates with complex CHD over 3 different time points (postnatal day 3-4, post-operative day 7-8, and post-operative day 13-14).
H1: Infants who receive trophic breastmilk feeds in the pre-operative period will demonstrate a more rapid decrease in intestinal permeability (improved postnatal intestinal maturation) over the first 2 weeks of life compared to those infants who were strictly NPO in the pre-operative period.
Specific Aim 2: To compare the duration (in days) until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs. NPO group.
H1: Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period.
Specific Aim 3: To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs. NPO group.
H1: The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: NPO pre-operative | Other | Other: Arm 1: NPO by mouth pre-operative1) Current care - NPO (nothing by mouth) postnatal intestinal function of neonates with complex CHD who receive enteral trophic breastmilk (10cc/kg/day) feeds (intervention) vs NPO (nothing by mouth) in the pre-operative period. |
| Arm 2: Fresh Breast Milk pre-operative | Active comparator | Other: Arm 2: Fresh Breast Milk pre-operative2) Intervention - Trophic mother's own fresh (non-frozen) breastmilk gavage feeds via nasogastric tube every 3 hours at 10 cc/kg/day |
Who may qualify
- Ages
- 37 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Study subjects will be male and female neonates admitted to MUSC PCICU or NICU prior to 72 hours of life who are gestational age ≥ 37 weeks.
- inpatient status at MUSC for a minimum of 48 hours prior to planned surgery and have a postnatal diagnosis of complex congenital heart disease - defined as a structural heart defect requiring cardiac surgery (reparative or palliative) prior to hospital discharge.
Key exclusion criteria (6 listed)
- Infants with hemodynamic instability in the pre-operative period requiring mechanical circulatory support or
- who have the presence of lactate > 3 after the first 24 hours of admission
- admission from home
- major congenital extracardiac abnormalities (i.e. renal, brain, GI)
- cardiac surgery will not be performed at MUSC, and
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 |
|---|---|---|
| Arm 1: NPO by mouth pre-operativeCurrent treatment for infants born with cardiac defects awaiting surgery is to keep them NPO pre-operatively. Arm 1 will make no changes to this current policy. | Other | Arm 1: NPO pre-operative |
| Arm 2: Fresh Breast Milk pre-operativeInfants randomized to Arm 2 of the study will receive their mother's own breast milk pre-operatively. | Other | Arm 2: Fresh Breast Milk pre-operative |
Primary outcome
Change in urine lactulose/mannitol ratio over time
Time frame: post-natal day 3-4 (baseline), post-op days 7 and 14
Specific Aim 1: compare decrease in intestinal permeability by urine lactulose: mannitol ratios of the trophic breastmilk fed group (intervention) vs. NPO (nothing by mouth) group (current care) amongst neonates with complex CHD over 3 different time points (postnatal day 3-4, post-operative day 7-8, and post-operative day 13-14).
2 secondary outcomes
Enteral Feeds
Time frame: Duration (in days) until goal enteral feeds are achieved, an expected average of 3 weeks
Intestinal Microflora Pattern
Time frame: 30 days 1st post-partum month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
- Background: PubMed 19619784Anderson JB, Beekman RH 3rd, Border WL, Kalkwarf HJ, Khoury PR, Uzark K, Eghtesady P, Marino BS. Lower weight-for-age z score adversely affects hospital length of stay after the bidirectional Glenn procedure in 100 infants with a single ventricle. J Thorac Cardiovasc Surg. 2009 Aug;138(2):397-404.e1. doi: 10.1016/j.jtcvs.2009.02.033. Epub 2009 May 23.
- Background: PubMed 16500550Kelleher DK, Laussen P, Teixeira-Pinto A, Duggan C. Growth and correlates of nutritional status among infants with hypoplastic left heart syndrome (HLHS) after stage 1 Norwood procedure. Nutrition. 2006 Mar;22(3):237-44. doi: 10.1016/j.nut.2005.06.008.
- Background: PubMed 14472142MEHRIZI A, DRASH A. Growth disturbance in congenital heart disease. J Pediatr. 1962 Sep;61:418-29. doi: 10.1016/s0022-3476(62)80373-4. No abstract available.
- Background: PubMed 19321898Owens JL, Musa N. Nutrition support after neonatal cardiac surgery. Nutr Clin Pract. 2009 Apr-May;24(2):242-9. doi: 10.1177/0884533609332086.
- Background: PubMed 19116405Schwalbe-Terilli CR, Hartman DH, Nagle ML, Gallagher PR, Ittenbach RF, Burnham NB, Gaynor JW, Ravishankar C. Enteral feeding and caloric intake in neonates after cardiac surgery. Am J Crit Care. 2009 Jan;18(1):52-7. doi: 10.4037/ajcc2009405.
- Background: PubMed 16488706Jeffries HE, Wells WJ, Starnes VA, Wetzel RC, Moromisato DY. Gastrointestinal morbidity after Norwood palliation for hypoplastic left heart syndrome. Ann Thorac Surg. 2006 Mar;81(3):982-7. doi: 10.1016/j.athoracsur.2005.09.001.
- Background: PubMed 19403484Pickard SS, Feinstein JA, Popat RA, Huang L, Dutta S. Short- and long-term outcomes of necrotizing enterocolitis in infants with congenital heart disease. Pediatrics. 2009 May;123(5):e901-6. doi: 10.1542/peds.2008-3216.
- Background: PubMed 16474253del Castillo SL, Moromisato DY, Dorey F, Ludwick J, Starnes VA, Wells WJ, Jeffries HE, Wong PC. Mesenteric blood flow velocities in the newborn with single-ventricle physiology: modified Blalock-Taussig shunt versus right ventricle-pulmonary artery conduit. Pediatr Crit Care Med. 2006 Mar;7(2):132-7. doi: 10.1097/01.PCC.0000200999.89777.92.
- Background: PubMed 15982432Harrison AM, Davis S, Reid JR, Morrison SC, Arrigain S, Connor JT, Temple ME. Neonates with hypoplastic left heart syndrome have ultrasound evidence of abnormal superior mesenteric artery perfusion before and after modified Norwood procedure. Pediatr Crit Care Med. 2005 Jul;6(4):445-7. doi: 10.1097/01.PCC.0000163674.53466.CA.
- Background: PubMed 11061778McElhinney DB, Hedrick HL, Bush DM, Pereira GR, Stafford PW, Gaynor JW, Spray TL, Wernovsky G. Necrotizing enterocolitis in neonates with congenital heart disease: risk factors and outcomes. Pediatrics. 2000 Nov;106(5):1080-7. doi: 10.1542/peds.106.5.1080.
- Background: PubMed 1561008Bernstein D, Bell JG, Kwong L, Castillo RO. Alterations in postnatal intestinal function during chronic hypoxemia. Pediatr Res. 1992 Mar;31(3):234-8. doi: 10.1203/00006450-199203000-00008.
- Background: PubMed 19014824Willis L, Thureen P, Kaufman J, Wymore E, Skillman H, da Cruz E. Enteral feeding in prostaglandin-dependent neonates: is it a safe practice? J Pediatr. 2008 Dec;153(6):867-9. doi: 10.1016/j.jpeds.2008.04.074.
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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.
Sinai C Zyblewski, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: NPO by mouth pre-operative and Arm 2: Fresh Breast Milk pre-operative in people with Congenital Heart Defects and Growth Failure, run by Medical University of South Carolina at 1 site in United States.
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 2 inclusion and 6 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in urine lactulose/mannitol ratio over time (time frame: post-natal day 3-4 (baseline), post-op days 7 and 14). 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 NCT01475357, which also lists 41 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 Oct 2014.