Congenital Gastrointestinal DisordersHM for CGDNCT02567292
Human Milk for Congenital Gastrointestinal Disorders
A study testing Human Milk in people with Congenital Gastrointestinal Disorders, run by Emory University at 1 site in United States.
Trial summary
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN). Read more about this study
- Who is it for?
- Ages 1 minute to 1 year
- Conditions the study is for
- Congenital Gastrointestinal Disorders
- What is being tested?
- Human Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 18 Jan 2022
- 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 1 minute to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to participating NICU at less than 7 days of age
- Birthweight >1250g and/or gestational age at birth >32 weeks
- Less than 7 days of enteral feedings
- Diagnosis of eligible primary "Congenital Gastointestinal Disorders" defined as: gastroschisis, omphalocele and intestinal atresias
- Consent to the use of donor human milk products
- Consent to participate in this study
Who cannot join
- Admission to participating NICU at >7 days of age
- Birthweight <1250g and/or gestational age <32 weeks
- Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus
- Evidence of significant liver dysfunction at time of enrollment (direct bilirubin >4 and transaminases elevated more than 2 SD above upper limit of normal for age)
- Liver malformations such as biliary atresia and choledochal cyst
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, 30322
About this study
Official title: Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
Read the detailed description
Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to treat. The CGD require surgery shortly after birth to correct the problems and recovery can take a long time.
During the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. Being on PN for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick.
Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt. It needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk (HM) is considered the ideal source of nutrition for all infants.
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
- Conditions
- Congenital Gastrointestinal Disorders
- Being tested
- Human Milk
- Keywords
- Digestive Disease and Disorders, Neonatal, Pediatric Disorders
- Medical subject headings
- Digestive System Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human MilkOther
Participants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants <37 weeks PMA and/or or weight <2,200g or PBCLN-002 for infants >37 weeks PMA and/or weight >2,200g)
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Control Group | No intervention | Approximately 150 patients with congenital gastrointestinal disorders who were treated in the neonatal intensive care unit (NICU) at Children's Healthcare of Atlanta-Egleston and other participating institutions from 2012 to 2015, who had non-human milk (HM) diets will be identified as retrospective controls using the electronic medical records system. |
| Exclusive Human Milk Diet Group | Experimental | A minimum of 150 patients with CGD admitted to participating NICUs who meet inclusion criteria and provide informed consent will be enrolled in the prospective arm of the study. These patients will be fed an EHMD comprised of mother's own milk (MOM) or pasteurized donor human milk (DM). Fortification will be provided with human milk derived human milk fortifier, either a human milk-based fortifier (Prolact+ H2MF®) for infants born at less than 37 weeks GA or <2,200g birth weight or the term-equivalent version (PBCLN-002) formulated for infants >37 weeks and/or >2,200g at birth. Infants will receive this EHMD until they have achieved full enteral feedings for 7 days with bowel in continuity Receives: Other: Human Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full enteral feeding
The number of days to achieve full enteral feeding after the initial human milk feeding
Measured: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary outcomes (9)
Number of days of parenteral nutrition
The total number of days parenteral nutrition is required.
Measured: Through study completion, up to 1 year
Growth
Compare growth parameters (weight, length and head circumference) as daily g/kg/d and z-scores birth to discharge
Measured: Through study completion, up to 1 year
Difference in conjugated bilirubin levels
The difference in average bilirubin level will be compared between the non-human milk diet (retrospective control group) and the breast milk diet group.
Measured: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Length of hospital stay
The length of hospital stay described as the number of days spent in the hospital
Measured: Through study completion, up to 6 months
Feeding interruptions
NPO for at least 24 hours. NPO due to elective surgeries or procedures will not be defined as feeding interruptions
Measured: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Feeding intolerance
Number of days when one or more feedings were held for clinical concerns
Measured: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Episodes of Necrotizing Enterocolitis
Number of episodes of Stage IIb NEC or greater
Measured: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Number of sepsis episodes
The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.
Measured: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Death rate
The number of deaths between participants who receive breast milk only diets as compared to the non-breast milk diet (retrospective control group while in the neonatal intensive care unit (NICU).
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start26 Jul 2018
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Emory 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Chatham Valley Foundation, Prolacta Bioscience
- Responsible party
- Principal investigator, Heidi Karpen, Emory University
- Investigators
- Heidi Karpen, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567292
- Sponsor's protocol ID
- IRB00080481
- Acronym
- HM for CGD
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2015
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shinnick JK, Wang E, Hulbert C, McCracken C, Sarson GY, Piazza A, Karpen H, Durham MM. Effects of a Breast Milk Diet on Enteral Feeding Outcomes of Neonates with Gastrointestinal Disorders. Breastfeed Med. 2016 Aug;11(6):286-292. doi: 10.1089/bfm.2016.0002. Epub 2016 Jun 22.
PubMed 27331420
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT02567292
- Acronym / sponsor ID
- HM for CGD / IRB00080481
- Conditions
- Congenital Gastrointestinal Disorders
- Keywords
- Digestive Disease and Disorders, Neonatal, Pediatric Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Chatham Valley Foundation, Prolacta Bioscience
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 2 Oct 2015 (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.
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
Detailed description
Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to treat. The CGD require surgery shortly after birth to correct the problems and recovery can take a long time.
During the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. Being on PN for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick.
Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt. It needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk (HM) is considered the ideal source of nutrition for all infants.
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Control Group | No intervention | –Approximately 150 patients with congenital gastrointestinal disorders who were treated in the neonatal intensive care unit (NICU) at Children's Healthcare of Atlanta-Egleston and other participating institutions from 2012 to 2015, who had non-human milk (HM) diets will be identified as retrospective controls using the electronic medical records system. |
| Exclusive Human Milk Diet Group | Experimental | Other: Human MilkA minimum of 150 patients with CGD admitted to participating NICUs who meet inclusion criteria and provide informed consent will be enrolled in the prospective arm of the study. These patients will be fed an EHMD comprised of mother's own milk (MOM) or pasteurized donor human milk (DM). Fortification will be provided with human milk derived human milk fortifier, either a human milk-based fortifier (Prolact+ H2MF®) for infants born at less than 37 weeks GA or <2,200g birth weight or the term-equivalent version (PBCLN-002) formulated for infants >37 weeks and/or >2,200g at birth. Infants will receive this EHMD until they have achieved full enteral feedings for 7 days with bowel in continuity |
Who may qualify
- Ages
- 1 minute to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Admission to participating NICU at less than 7 days of age
- Birthweight >1250g and/or gestational age at birth >32 weeks
- Less than 7 days of enteral feedings
- Diagnosis of eligible primary "Congenital Gastointestinal Disorders" defined as: gastroschisis, omphalocele and intestinal atresias
- Consent to the use of donor human milk products
Key exclusion criteria (6 listed)
- Admission to participating NICU at >7 days of age
- Birthweight <1250g and/or gestational age <32 weeks
- Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus
- Evidence of significant liver dysfunction at time of enrollment (direct bilirubin >4 and transaminases elevated more than 2 SD above upper limit of normal for age)
- Liver malformations such as biliary atresia and choledochal cyst
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 |
|---|---|---|
| Human MilkParticipants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants <37 weeks PMA and/or or weight <2,200g or PBCLN-002 for infants >37 weeks PMA and/or weight >2,200g) | Other | Exclusive Human Milk Diet Group |
Primary outcome
Time to full enteral feeding
Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
The number of days to achieve full enteral feeding after the initial human milk feeding
9 secondary outcomes
Number of days of parenteral nutrition
Time frame: Through study completion, up to 1 year
Growth
Time frame: Through study completion, up to 1 year
Difference in conjugated bilirubin levels
Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Length of hospital stay
Time frame: Through study completion, up to 6 months
Feeding interruptions
Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Feeding intolerance
Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Episodes of Necrotizing Enterocolitis
Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Number of sepsis episodes
Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Death rate
Time frame: Through study completion, up to 1 year
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 28 Aug 2023.
- Results publication: PubMed 27331420Shinnick JK, Wang E, Hulbert C, McCracken C, Sarson GY, Piazza A, Karpen H, Durham MM. Effects of a Breast Milk Diet on Enteral Feeding Outcomes of Neonates with Gastrointestinal Disorders. Breastfeed Med. 2016 Aug;11(6):286-292. doi: 10.1089/bfm.2016.0002. Epub 2016 Jun 22.
- Individual participant dataSharing planned: No
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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.
Heidi Karpen, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk in people with Congenital Gastrointestinal Disorders, run by Emory University 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 6 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 28 Aug 2023. 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?
Time to full enteral feeding (time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)). 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 NCT02567292, which also lists 1 linked publication.
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 28 Aug 2023.