Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
27 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-10-14
Study Completion Date
2026-12-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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
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Gastroschisis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Oral Care with Sterile Water
Infants will receive oral care with sterile water when mother's milk is not available.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
• Infants with a primary diagnosis of gastroschisis
Exclusion Criteria
* 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
* 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
Maximum Eligible Age
3 Days
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Baylor College of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Amy Hair
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Amy B Hair, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Texas Children's Hospital Fetal Center and Newborn Center
Houston, Texas, United States
Site Status
Countries
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United States
References
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BACKGROUND
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BACKGROUND
Lee 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.
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
Rodriguez 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.
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
Shah SK, Aroom KR, Walker PA, Xue H, Jimenez F, Gill BS, Cox CS Jr, Moore-Olufemi SD. Effects of nonocclusive mesenteric hypertension on intestinal function: implications for gastroschisis-related intestinal dysfunction. Pediatr Res. 2012 Jun;71(6):668-74. doi: 10.1038/pr.2012.20. Epub 2012 Feb 14.
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BACKGROUND
Dalton BG, Gonzalez KW, Reddy SR, Hendrickson RJ, Iqbal CW. Improved outcomes for inborn babies with uncomplicated gastroschisis. J Pediatr Surg. 2017 Jul;52(7):1132-1134. doi: 10.1016/j.jpedsurg.2016.12.003. Epub 2016 Dec 18.
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Hook-Dufresne DM, Yu X, Bandla V, Imseis E, Moore-Olufemi SD. The economic burden of gastroschisis: costs of a birth defect. J Surg Res. 2015 May 1;195(1):16-20. doi: 10.1016/j.jss.2015.01.036. Epub 2015 Jan 28.
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Balgi S, Singhal S, Mueller G, Batton B. Feeding Intolerance and Poor Growth in Infants with Gastroschisis: Longitudinal Experience with Consecutive Patients over Thirteen Years. J Neonatal Surg. 2015 Oct 1;4(4):42. eCollection 2015 Oct-Dec.
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Aljahdali A, Mohajerani N, Skarsgard ED; Canadian Pediatric Surgery Network (CAPSNet). Effect of timing of enteral feeding on outcome in gastroschisis. J Pediatr Surg. 2013 May;48(5):971-6. doi: 10.1016/j.jpedsurg.2013.02.014.
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Neu J, Pammi M. Pathogenesis of NEC: Impact of an altered intestinal microbiome. Semin Perinatol. 2017 Feb;41(1):29-35. doi: 10.1053/j.semperi.2016.09.015. Epub 2016 Dec 13.
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Westerbeek EA, van den Berg A, Lafeber HN, Knol J, Fetter WP, van Elburg RM. The intestinal bacterial colonisation in preterm infants: a review of the literature. Clin Nutr. 2006 Jun;25(3):361-8. doi: 10.1016/j.clnu.2006.03.002. Epub 2006 May 4.
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Meropol SB, Edwards A. Development of the infant intestinal microbiome: A bird's eye view of a complex process. Birth Defects Res C Embryo Today. 2015 Dec;105(4):228-39. doi: 10.1002/bdrc.21114. Epub 2015 Dec 11.
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Magne F, Suau A, Pochart P, Desjeux JF. Fecal microbial community in preterm infants. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):386-92. doi: 10.1097/01.mpg.0000179855.38543.85. No abstract available.
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Sohn K, Kalanetra KM, Mills DA, Underwood MA. Buccal administration of human colostrum: impact on the oral microbiota of premature infants. J Perinatol. 2016 Feb;36(2):106-11. doi: 10.1038/jp.2015.157. Epub 2015 Dec 10.
Reference Type
BACKGROUND
Other Identifiers
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H41227
Identifier Type: -
Identifier Source: org_study_id
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