GastroschisisNCT03393832
Oral Care in Infants With Gastroschisis
An observational study of Gastroschisis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are significant complications related to feeding intolerance and infections. Recently, oral care with breast milk has been studied in extremely premature infants and has been shown to improve both feeding tolerance and protect against… Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Gastroschisis
- Type of treatment
- Pill or oral medicine
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2017to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants with a diagnosis of gastroschisis are identified either prenatally through the Texas Children's Hospital Fetal Center or upon admission to the Texas Children's Hospital Neonatal Intensive Care Unit (NICU).
Who may be able to join
- Infants with a primary diagnosis of gastroschisis
Who cannot join
- Gestational age less than 30 weeks
- Birth weight less than 1,000 g
- Other major congenital anomalies or clinically significant heart disease
- First dose of oral care greater than 72 hours after birth
- Early transfer to another institution
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital Fetal Center and Newborn Center
Houston, Texas, 770230
About this study
Official title: Oral Care: An Important Adjunctive Therapy to Improve Feeding Tolerance in Infants With Gastroschisis
Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are significant complications related to feeding intolerance and infections. Recently, oral care with breast milk has been studied in extremely premature infants and has been shown to improve both feeding tolerance and protect against infection. Though only studied in premature infants, it is likely that other populations of patients can benefit form oral care as well. This is a prospective observational cohort study looking at infants with gastroschisis admitted to the Texas Children's Hospital Newborn Center NICU (level II and level IV) who receive oral care with mother's milk or sterile water when mother's milk is not available. The study is aimed to demonstrate the benefits of oral care with breast milk in infants with gastroschisis. Additionally, the investigators will evaluate how oral care with breast milk affects the intestinal bacterial environment and how oral care with breast milk affects the secretion of certain proteins from the salivary gland.
Primary hypothesis: The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis.
Read more
Secondary hypothesis:
- Oral care with breast milk will decrease the days to start enteral feeds after primary surgical closure inpatients with gastroschisis.
- Oral care with breast milk will decrease the days to reach full enteral feeds of 140 cc/kg/day in patients with gastroschisis.
- Oral care with breast milk will decrease length of stay in patients with gastroschisis.
- Oral care with breast milk will increase secretion of certain proteins, such as vascular endothelial growth factor, from the salivary gland.
Read the detailed description
Breast milk is recommended for most infants by the American Academy of Pediatrics as there are multiple benefits. However, some infants, such as extremely premature infants, are unable to receive enteral nutrition for a variety of clinical reasons. In order provide these infants with some of the benefits of mother's milk, a novel adjunctive therapy called oral care has been developed. Oral care consists of applying mother's breast milk to the buccal mucosa. Oral care has been studied in the premature infant population and been shown to improve both feeding tolerance and to provide immune protection. Although only studied in the premature population, many institutions including Texas Children's Hospital have adopted oral care as a standard of care for all infants as oral care poses minimal risk to the patient and has many potential benefits. Gastroschisis is a rare abdominal wall defect. Although the survival rate for infants with gastroschisis is high, there are significant morbidities related to feeding intolerance and infection. The investigators believe that this population of patients will also benefit from oral care.
The mechanism by which oral care works is not completely understood. It is theorized that oral care stimulates the oropharyngeal-lymphoid tissue in the buccal mucosa. Additional mechanisms include alteration of the intestinal microbiome. The intestinal microbiome is the millions of microorganisms that line the intestine. Normally, there is a mutually beneficial relationship. The intestinal microbiome is altered by many factors, including gestational age, antibiotic use, type of delivery, etc. Alterations in the microbiome can be detrimental and cause severe diseases such as necrotizing enterocolitis. Thus, far studies have shown that oral care alters the oral microbiome to include more healthy bacteria. The investigators believe that oral care with breast milk will be associated with a more diverse fecal microbiota. Finally, the investigators will evaluate a novel mechanism by which the investigators believe oral care is protective; via increased salivary gland secretion of certain proteins important for healing. In particular, saliva contains vascular endothelial growth factor, which is important for palatal wound healing and alimentary tract healing.
- Conditions
- Gastroschisis
- Keywords
- Oral care, Oropharyngeal mother's milk
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral Care with Mother's Milk | All infants admitted to the Texas Children's Hospital NICUs who have mother's milk available will receive oral care with mother's milk. | |
| Oral Care with Sterile Water | Infants will receive oral care with sterile water when mother's milk is not available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Outcome
The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis.
Measured: 4 weeks
Secondary outcomes (4)
Days to start enteral feeds after primary surgical closure between the two cohorts
The first secondary objective is to compare the days to start enteral feeds after primary surgical closure between the two cohorts.
Measured: The current average time to start feeds after surgical closure is 15 days.
Days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts
The second secondary objective is to compare days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts.
Measured: The current average time to reach full enteral feeds is 105 days.
Length of stay between the two study cohorts
The third secondary objective is to compare length of stay between the two study cohorts.
Measured: The current average length of stay is 70 days.
Salivary Gland Outcome: levels of salivary proteins between the two study cohorts
The final secondary objective is to compare levels of salivary proteins between the two study cohorts from birth to when infant achieves full enteral feeds of 140 cc/kg/day, using either ELISA or Luminex Mulitplex assays.
Measured: The average is 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start14 Oct 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Hair, Baylor College of Medicine
- Investigators
- Amy B Hair, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393832
- Sponsor's protocol ID
- H41227
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2018
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keswani SG, Balaji S, Le LD, Leung A, Parvadia JK, Frischer J, Yamano S, Taichman N, Crombleholme TM. Role of salivary vascular endothelial growth factor (VEGF) in palatal mucosal wound healing. Wound Repair Regen. 2013 Jul-Aug;21(4):554-62. doi: 10.1111/wrr.12065. Epub 2013 Jun 11.
PubMed 23758212Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
PubMed 22371471Rodriguez NA, Meier PP, Groer MW, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 Jan;29(1):1-7. doi: 10.1038/jp.2008.130. Epub 2008 Sep 4.
PubMed 18769379Gephart SM, Weller M. Colostrum as oral immune therapy to promote neonatal health. Adv Neonatal Care. 2014 Feb;14(1):44-51. doi: 10.1097/ANC.0000000000000052.
PubMed 24472888Rodriguez NA, Vento M, Claud EC, Wang CE, Caplan MS. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:453. doi: 10.1186/s13063-015-0969-6.
PubMed 26458907Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.
PubMed 25624376Thibeau S, Boudreaux C. Exploring the use of mothers' own milk as oral care for mechanically ventilated very low-birth-weight preterm infants. Adv Neonatal Care. 2013 Jun;13(3):190-7. doi: 10.1097/ANC.0b013e318285f8e2.
PubMed 23722491Rodriguez NA, Caplan MS. Oropharyngeal administration of mother's milk to prevent necrotizing enterocolitis in extremely low-birth-weight infants: theoretical perspectives. J Perinat Neonatal Nurs. 2015 Jan-Mar;29(1):81-90. doi: 10.1097/JPN.0000000000000087.
PubMed 25633403McCallie KR, Lee HC, Mayer O, Cohen RS, Hintz SR, Rhine WD. Improved outcomes with a standardized feeding protocol for very low birth weight infants. J Perinatol. 2011 Apr;31 Suppl 1:S61-7. doi: 10.1038/jp.2010.185.
PubMed 21448207Seigel JK, Smith PB, Ashley PL, Cotten CM, Herbert CC, King BA, Maynor AR, Neill S, Wynn J, Bidegain M. Early administration of oropharyngeal colostrum to extremely low birth weight infants. Breastfeed Med. 2013 Dec;8(6):491-5. doi: 10.1089/bfm.2013.0025. Epub 2013 Jun 27.
PubMed 23805944Rodriguez NA, Meier PP, Groer MW, Zeller JM, Engstrom JL, Fogg L. A pilot study to determine the safety and feasibility of oropharyngeal administration of own mother's colostrum to extremely low-birth-weight infants. Adv Neonatal Care. 2010 Aug;10(4):206-12. doi: 10.1097/ANC.0b013e3181e94133.
PubMed 20697221Spinelli M, Frigerio A, Montali L, Fasolo M, Spada MS, Mangili G. 'I still have difficulties feeling like a mother': The transition to motherhood of preterm infants mothers. Psychol Health. 2016;31(2):184-204. doi: 10.1080/08870446.2015.1088015. Epub 2015 Oct 8.
PubMed 26359768Durfee SM, Benson CB, Adams SR, Ecker J, House M, Jennings R, Katz D, Pettigrew C, Wolfberg A. Postnatal outcome of fetuses with the prenatal diagnosis of gastroschisis. J Ultrasound Med. 2013 Mar;32(3):407-12. doi: 10.7863/jum.2013.32.3.407.
PubMed 23443180O'Connell RV, Dotters-Katz SK, Kuller JA, Strauss RA. Gastroschisis: A Review of Management and Outcomes. Obstet Gynecol Surv. 2016 Sep;71(9):537-44. doi: 10.1097/OGX.0000000000000344.
PubMed 27640608Gamba P, Midrio P. Abdominal wall defects: prenatal diagnosis, newborn management, and long-term outcomes. Semin Pediatr Surg. 2014 Oct;23(5):283-90. doi: 10.1053/j.sempedsurg.2014.09.009. Epub 2014 Sep 4.
PubMed 25459013
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care: An Important Adjunctive Therapy to Improve Feeding Tolerance in Infants With Gastroschisis
- ClinicalTrials.gov ID
- NCT03393832
- Acronym / sponsor ID
- H41227
- Conditions
- Gastroschisis
- Keywords
- Oral care, Oropharyngeal mother's milk
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jan 2018 (actual)
- 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.
Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are significant complications related to feeding intolerance and infections. Recently, oral care with breast milk has been studied in extremely premature infants and has been shown to improve both feeding tolerance and protect against infection. Though only studied in premature infants, it is likely that other populations of patients can benefit form oral care as well. This is a prospective observational cohort study looking at infants with gastroschisis admitted to the Texas Children's Hospital Newborn Center NICU (level II and level IV) who receive oral care with mother's milk or sterile water when mother's milk is not available. The study is aimed to demonstrate the benefits of oral care with breast milk in infants with gastroschisis. Additionally, the investigators will evaluate how oral care with breast milk affects the intestinal bacterial environment and how oral care with breast milk affects the secretion of certain proteins from the salivary gland.
Primary hypothesis: The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis.
Secondary hypothesis:
- Oral care with breast milk will decrease the days to start enteral feeds after primary surgical closure inpatients with gastroschisis.
- Oral care with breast milk will decrease the days to reach full enteral feeds of 140 cc/kg/day in patients with gastroschisis.
- Oral care with breast milk will decrease length of stay in patients with gastroschisis.
- Oral care with breast milk will increase secretion of certain proteins, such as vascular endothelial growth factor, from the salivary gland.
Detailed description
Breast milk is recommended for most infants by the American Academy of Pediatrics as there are multiple benefits. However, some infants, such as extremely premature infants, are unable to receive enteral nutrition for a variety of clinical reasons. In order provide these infants with some of the benefits of mother's milk, a novel adjunctive therapy called oral care has been developed. Oral care consists of applying mother's breast milk to the buccal mucosa. Oral care has been studied in the premature infant population and been shown to improve both feeding tolerance and to provide immune protection. Although only studied in the premature population, many institutions including Texas Children's Hospital have adopted oral care as a standard of care for all infants as oral care poses minimal risk to the patient and has many potential benefits. Gastroschisis is a rare abdominal wall defect. Although the survival rate for infants with gastroschisis is high, there are significant morbidities related to feeding intolerance and infection. The investigators believe that this population of patients will also benefit from oral care.
The mechanism by which oral care works is not completely understood. It is theorized that oral care stimulates the oropharyngeal-lymphoid tissue in the buccal mucosa. Additional mechanisms include alteration of the intestinal microbiome. The intestinal microbiome is the millions of microorganisms that line the intestine. Normally, there is a mutually beneficial relationship. The intestinal microbiome is altered by many factors, including gestational age, antibiotic use, type of delivery, etc. Alterations in the microbiome can be detrimental and cause severe diseases such as necrotizing enterocolitis. Thus, far studies have shown that oral care alters the oral microbiome to include more healthy bacteria. The investigators believe that oral care with breast milk will be associated with a more diverse fecal microbiota. Finally, the investigators will evaluate a novel mechanism by which the investigators believe oral care is protective; via increased salivary gland secretion of certain proteins important for healing. In particular, saliva contains vascular endothelial growth factor, which is important for palatal wound healing and alimentary tract healing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Care with Mother's Milk | – | –All infants admitted to the Texas Children's Hospital NICUs who have mother's milk available will receive oral care with mother's milk. |
| Oral Care with Sterile Water | – | –Infants will receive oral care with sterile water when mother's milk is not available. |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with a diagnosis of gastroschisis are identified either prenatally through the Texas Children's Hospital Fetal Center or upon admission to the Texas Children's Hospital Neonatal Intensive Care Unit (NICU).
Key inclusion criteria (1 listed)
- Infants with a primary diagnosis of gastroschisis
Key exclusion criteria (5 listed)
- Gestational age less than 30 weeks
- Birth weight less than 1,000 g
- Other major congenital anomalies or clinically significant heart disease
- First dose of oral care greater than 72 hours after birth
- Early transfer to another institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome Outcome
Time frame: 4 weeks
The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis.
4 secondary outcomes
Days to start enteral feeds after primary surgical closure between the two cohorts
Time frame: The current average time to start feeds after surgical closure is 15 days.
Days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts
Time frame: The current average time to reach full enteral feeds is 105 days.
Length of stay between the two study cohorts
Time frame: The current average length of stay is 70 days.
Salivary Gland Outcome: levels of salivary proteins between the two study cohorts
Time frame: The average is 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 23758212Keswani SG, Balaji S, Le LD, Leung A, Parvadia JK, Frischer J, Yamano S, Taichman N, Crombleholme TM. Role of salivary vascular endothelial growth factor (VEGF) in palatal mucosal wound healing. Wound Repair Regen. 2013 Jul-Aug;21(4):554-62. doi: 10.1111/wrr.12065. Epub 2013 Jun 11.
- Background: PubMed 22371471Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
- Background: PubMed 18769379Rodriguez NA, Meier PP, Groer MW, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 Jan;29(1):1-7. doi: 10.1038/jp.2008.130. Epub 2008 Sep 4.
- Background: PubMed 24472888Gephart SM, Weller M. Colostrum as oral immune therapy to promote neonatal health. Adv Neonatal Care. 2014 Feb;14(1):44-51. doi: 10.1097/ANC.0000000000000052.
- Background: PubMed 26458907Rodriguez NA, Vento M, Claud EC, Wang CE, Caplan MS. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:453. doi: 10.1186/s13063-015-0969-6.
- Background: PubMed 25624376Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.
- Background: PubMed 23722491Thibeau S, Boudreaux C. Exploring the use of mothers' own milk as oral care for mechanically ventilated very low-birth-weight preterm infants. Adv Neonatal Care. 2013 Jun;13(3):190-7. doi: 10.1097/ANC.0b013e318285f8e2.
- Background: PubMed 25633403Rodriguez NA, Caplan MS. Oropharyngeal administration of mother's milk to prevent necrotizing enterocolitis in extremely low-birth-weight infants: theoretical perspectives. J Perinat Neonatal Nurs. 2015 Jan-Mar;29(1):81-90. doi: 10.1097/JPN.0000000000000087.
- Background: PubMed 21448207McCallie KR, Lee HC, Mayer O, Cohen RS, Hintz SR, Rhine WD. Improved outcomes with a standardized feeding protocol for very low birth weight infants. J Perinatol. 2011 Apr;31 Suppl 1:S61-7. doi: 10.1038/jp.2010.185.
- Background: PubMed 23805944Seigel JK, Smith PB, Ashley PL, Cotten CM, Herbert CC, King BA, Maynor AR, Neill S, Wynn J, Bidegain M. Early administration of oropharyngeal colostrum to extremely low birth weight infants. Breastfeed Med. 2013 Dec;8(6):491-5. doi: 10.1089/bfm.2013.0025. Epub 2013 Jun 27.
- Background: PubMed 20697221Rodriguez NA, Meier PP, Groer MW, Zeller JM, Engstrom JL, Fogg L. A pilot study to determine the safety and feasibility of oropharyngeal administration of own mother's colostrum to extremely low-birth-weight infants. Adv Neonatal Care. 2010 Aug;10(4):206-12. doi: 10.1097/ANC.0b013e3181e94133.
- Background: PubMed 26359768Spinelli M, Frigerio A, Montali L, Fasolo M, Spada MS, Mangili G. 'I still have difficulties feeling like a mother': The transition to motherhood of preterm infants mothers. Psychol Health. 2016;31(2):184-204. doi: 10.1080/08870446.2015.1088015. Epub 2015 Oct 8.
- 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.
Amy B Hair, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroschisis, run by Baylor College of Medicine 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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Microbiome Outcome (time frame: 4 weeks). 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 NCT03393832, which also lists 36 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 3 Feb 2026.