Clinical trial NCT02486263: Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
Official title: Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: infant
esophagitis
neonate
GERD
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Ohio State University
First posted: 2015-07-01
Enrollment: 76
Sex: ALL
Minimum age (years): 34
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.

In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.

Detailed description: Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.

The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).

Eligibility criteria: Inclusion Criteria:

* Hospitalized infants with aerodigestive or GERD symptoms
* Gestational age ≤42 weeks
* Premature infants are eligible at 34 weeks postmenstrual age (PMA)
* Enteral or Oral Fed
* Average daily total feeding volume ≥ 150ml/kg/day
* Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula

Exclusion Criteria:

* Known genetic, metabolic or syndromic disease
* Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
* Gastrointestinal malformations and surgical gastrointestinal conditions

Primary outcomes:
measure: CLINICAL OUTCOME OF FEEDING SUCCESS
timeFrame: Up to 5 weeks after enrollment
measure: MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes
timeFrame: 5 weeks
Secondary outcomes:
measure: CLINICAL OUTCOMES: Growth Outcome Measure
timeFrame: at 5 weeks
measure: CLINICAL OUTCOME: Development Outcome Measures
timeFrame: Up to 1 year age
measure: CLINICAL OUTCOME: Respiratory Outcome Measures
timeFrame: at discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Research Institute at Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Research Institute at Nationwide Children's Hospital
name: Sudarshan R Jadcherla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jadcherla SR, Hasenstab KA, Wei L, Osborn EK, Viswanathan S, Gulati IK, Slaughter JL, Di Lorenzo C. Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial. Pediatr Res. 2021 Feb;89(3):645-652. doi: 10.1038/s41390-020-0932-4. Epub 2020 May 7.
citation: Sultana Z, Hasenstab KA, Moore RK, Osborn EK, Yildiz VO, Wei L, Slaughter JL, Jadcherla SR. Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux. Gastro Hep Adv. 2022;1(5):869-881. doi: 10.1016/j.gastha.2022.06.004. Epub 2022 Jun 20.
citation: Jadcherla SR, Hasenstab KA, Gulati IK, Helmick R, Ipek H, Yildiz V, Wei L. Impact of Feeding Strategies With Acid Suppression on Esophageal Reflexes in Human Neonates With Gastroesophageal Reflux Disease: A Single-Blinded Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Nov;11(11):e00249. doi: 10.14309/ctg.0000000000000249.