Clinical trial NCT04246333: Duodenal Feeds in Very Low Birth Weight Infants
Official title: Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: BPD - Bronchopulmonary Dysplasia
VLBW - Very Low Birth Weight Infant
Feeding Disorder Neonatal
Feeding; Difficult, Newborn
Premature Birth
Chronic Lung Disease of Prematurity
Keywords: Duodenal feeds
Transpyloric feeds
Bronchopulmonary Dysplasia
BPD
Premature infant
Neonate
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.

Detailed description: The primary outcome of this study is the safety and feasibility of duodenal feeds in very low birth weight infants. The secondary outcomes are various measures related to growth, respiratory support, comorbidities, and hospitalization.

Eligibility of infants admitted to the Johns Hopkins All Children's Neonatal Intensive Care Unit (NICU) will be determined based on inclusion and exclusion criteria. Eligible infants will be recruited and enrolled by 14 days of life after informed consent is obtained. Randomization of the infants into two groups- investigational continuous Duodenal Feeds (DF) or standard Gastric Feeds (GF) - will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds.

All enrolled infants will be fed per the institutional feeding protocol. Once infants advance past 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups in a 1:1 block randomization using blinded envelopes. Multiple gestation infants will be randomized individually.

Placement of gastric tubes will be per standard of practice, and insertion of duodenal tube will be per manual of operations. Continuous duodenal feeds will be provided over 24 hours as a continuous infusion through a nasoduodenal or oro-duodenal tube. Standard gastric feeds will be infused via a nasogastric or orogastric tube per the instructions of the medical team. Gastric feeds are provided as standard of care in the NICU; intermittent bolus feeds over 15-60 minutes. Feeding time may be prolonged by the medical team, for longer than 60 minutes and possibly even be given continuously, for various reasons (emesis, reflux, apnea, bradycardia, etc.) and will be monitored and recorded. Feed volume and advancement will continue to be determined by standardized institutional feeding guidelines. Decision to provide further fortification of feeds beyond institutional guidelines will be determined by the medical team and not standardized in this protocol. Once full enteral feeds are achieved (total fluid goal of at least 140mL/kg/day), patients will continue to receive feeds via the designated route.

An institutional "Infant Driven Feeding Guideline" is utilized to evaluate readiness to orally feed and to transition premature infants from enteral to oral feeds. Once an infant is eligible to receive oral feeds per this guideline (32 weeks postmenstrual age, and tolerating ≤2L flow via nasal cannula for at least 24 hours), the study will allow the medical team to transition infants in the DF group to gastric feeds. Regarding transitioning infant from duodenal to gastric feeds, infants are initially placed on continuous gastric feeds, and once the participants have demonstrated tolerance (no evidence of reflux, increased respiratory support, emesis), the participants are then transitioned to bolus gastric feeds progressively. Infants may be allowed to orally feed during this transition period if the participants meet the appropriate infant driven feeding scores per protocol.

All infants in this study will be monitored for primary and secondary outcomes through the duration of admission and up until the time of discharge. Safety events will be frequently monitored for throughout the duration of admission and addressed immediately if warranted.

Eligibility criteria: Inclusion Criteria:

* Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life
* Infants with a birth weight \<1251g

Exclusion Criteria:

* First obtained pH \<7.0
* APGAR \<5 at 5 minutes (The Apgar score is a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. Appearance, Pulse, Grimace, Activity, Respiration (APGAR))
* Infants on hydrocortisone for hypotension prior to randomization
* Infants with intrauterine growth restriction (IUGR) defined by birth weight ≤10th percentile for gestational age
* Infants with congenital anomalies, including but not limited to: Chromosomal abnormalities;Structural airway or pulmonary abnormalities (e.g. tracheoesophageal fistulas, cleft palate, congenital pulmonary adenomatous malformation, etc.); Abdominal anomalies requiring surgical interventions (e.g. intestinal atresia, intestinal webs, gastroschisis, omphalocele, anal atresia); Major cardiac anomalies
* Infants with a history of intestinal perforation or NEC
* Presence of gastrostomy tube
* Infants who have not been initiated on any volume of enteral feeds by 10 days of life

Primary outcomes:
measure: Number of successful placements of duodenal tubes
timeFrame: 12 months
measure: Safety as assessed by number of intestinal perforations
timeFrame: 12 months
Secondary outcomes:
measure: Supplemental oxygen requirement
timeFrame: duration of hospitalization, up to 15 months
measure: Number of participants with Bronchopulmonary Dysplasia
timeFrame: 15 months
measure: Number of deaths during hospitalization
timeFrame: 15 months
measure: Number of days of mechanical ventilation
timeFrame: 15 months
measure: Number of participants with late-onset sepsis
timeFrame: 15 months
measure: Central line days
timeFrame: 15 months
measure: Number of participants with necrotizing enterocolitis
timeFrame: 15 months
measure: Number of replaced enteral tubes
timeFrame: 15 months
measure: Number of Radiographs related to enteral tube placement
timeFrame: 15 months
measure: Weight percentile at 36 weeks postmenstrual age
timeFrame: At 36 weeks
measure: Height percentile at 36 weeks postmenstrual age
timeFrame: At 36 weeks
measure: Head circumference percentile at 36 weeks postmenstrual age
timeFrame: At 36 weeks
measure: Z-scores for weight at 36 weeks postmenstrual age
timeFrame: At 36 weeks
measure: Z-scores for height at 36 weeks postmenstrual age
timeFrame: At 36 weeks
measure: Z-scores for head circumference at 36 weeks postmenstrual age
timeFrame: At 36 weeks
measure: Daily daily weight gain
timeFrame: At 36 weeks
measure: Length of stay
timeFrame: duration of hospitalization, up to 15 months
measure: Need for excess fortification of feeds
timeFrame: 15 months
measure: Use of postnatal dexamethasone
timeFrame: 15 months
measure: Use of chronic diuretics
timeFrame: 15 months
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Noura Nickel, MD
role: PRINCIPAL_INVESTIGATOR
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