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Trial record 5 of 31 for:    "Gastroschisis"

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 : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Hair, Baylor College of Medicine

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 study is a randomized controlled trial aimed to demonstrate the benefits of oral care with all breast milk (either mother's milk or pasteurized donor breast milk) in infants with gastroschisis. Additionally, the investigators will evaluate how oral care with all breast milk affects the intestinal bacterial environment and how oral care with all 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 the two study arms 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 Intervention/treatment Phase
Gastroschisis Other: Oral Care with sterile water Other: Oral Care with all breast milk Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot, randomized controlled trial
Masking: Double (Participant, Care Provider)
Masking Description: Oral care syringes will be covered with yellow tape.
Primary Purpose: Supportive Care
Official Title: Oral Care: An Important Adjunctive Therapy in Infants With Gastroschisis
Actual Study Start Date : October 14, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Oral Care with Sterile Water
The Placebo group will receive oral care with sterile water.
Other: Oral Care with sterile water
Administration of 0.2 ml of sterile water to buccal mucosa, every 3-4 hours for 4 weeks beginning within 72 hours of birth.

Experimental: Oral Care with all Breast Milk
The Experimental group will receive oral care with all breast milk. Mother's milk will be used first. When mother's milk is not available, pasteurized donor breast milk will be used.
Other: Oral Care with all breast milk
Administration of 0.2 ml of breast milk (either mother's milk or pasteurized donor breast milk) to buccal mucosa, every 3-4 hours for 4 weeks beginning within 72 hours of birth.




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 the two study arms using a paired analysis.


Secondary Outcome Measures :
  1. Clinical Outcome 1 [ 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 study arms.

  2. Clinical Outcome 2 [ 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 arms.

  3. Clinical Outcome 3 [ 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 arms.

  4. Salivary Gland Outcome [ Time Frame: 6 weeks ]
    The final secondary objective is to compare levels of salivary proteins between the two study arms using either ELISA or Luminex Mulitplex assays.



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 832-826-1380 abhair@bcm.tmc.edu
Contact: Elizabeth J Sager, MD 832-826-1380 elizabeth.sager@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    832-826-1380    abhair@bcm.tmc.edu   
Contact: Elizabeth J Sager, MD    832-826-1380    elizabeth.sager@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Amy B Hair, MD Baylor College of Medicine
Principal Investigator: Elizabeth J Sager, MD Baylor College of Medicine

Publications:

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Responsible Party: Amy Hair, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03393832     History of Changes
Other Study ID Numbers: H41227
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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