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Oral Care in Infants With Gastroschisis

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ClinicalTrials.gov Identifier: NCT03393832
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Amy Hair, Baylor College of Medicine

Study Description
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Brief 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 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.

Condition or disease
Gastroschisis

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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Care: An Important Adjunctive Therapy to Improve Feeding Tolerance in Infants With Gastroschisis
Actual Study Start Date : October 14, 2017
Estimated Primary Completion Date : October 14, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    The first secondary objective is to compare the days to start enteral feeds after primary surgical closure between the two cohorts.

  2. 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. ]
    The second secondary objective is to compare days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts.

  3. Length of stay between the two study cohorts [ Time Frame: The current average length of stay is 70 days. ]
    The third secondary objective is to compare length of stay between the two study cohorts.

  4. Salivary Gland Outcome: levels of salivary proteins between the two study cohorts [ Time Frame: The average is 6 weeks. ]
    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.


Biospecimen Retention:   Samples With DNA
Stool samples will be collected daily for first week of life and then weekly for three weeks to study the intestinal microbiome and the relative abundance of various bacteria. Oral care samples (mother's own milk) will be collected at time of stool collection to characterize and compare the abundance of various bacteria in the oral care versus the stool samples. Saliva samples will be collected at the following time-points to identify and quantify salivary gland proteins: one baseline sample following study enrollment (0-72 hours), one before surgical closure of gastroschisis, one daily from DOL 10 to when infant reaches full enteral feeds (140 cc/kg/day), and one sample after infant reaches full enteral feeds. All collected samples will be frozen and stored in the Neonatal Nutrition Research Program Biorepository freezer for up to two years or until used, whichever is earlier. All samples will be discarded as medical waste if and when a subject is withdrawn from the study.

Eligibility Criteria
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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393832


Contacts
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Contact: Amy B Hair, MD 832-826-1398 abhair@bcm.tmc.edu
Contact: Heeju Yang 832-826-7456 heeju.yang@bcm.edu

Locations
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United States, Texas
Texas Children's Hospital Fetal Center and Newborn Center Recruiting
Houston, Texas, United States, 770230
Contact: Amy B Hair, MD    832-826-1398    abhair@bcm.tmc.edu   
Contact: Heeju Yang    832-826-7456    heeju.yang@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Amy B Hair, MD Baylor College of Medicine
More Information
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Publications:

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Responsible Party: Amy Hair, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03393832    
Other Study ID Numbers: H41227
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Hair, Baylor College of Medicine:
Oral care
Oropharyngeal mother's milk
Additional relevant MeSH terms:
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Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
 Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical