Oral Care in Infants With Gastroschisis
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/5/2019 |
| Start Date: | October 14, 2017 |
| End Date: | August 1, 2019 |
| Contact: | Amy B Hair, MD |
| Email: | abhair@bcm.tmc.edu |
| Phone: | 832-826-1380 |
Oral Care: An Important Adjunctive Therapy 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 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.
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.
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.
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.
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
We found this trial at
1
site
6651 South Main Street
Houston, Texas 77023
Houston, Texas 77023
Phone: 832-826-1380
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