RECRUITING

Duodenal Feeds in Very Low Birth Weight Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants

Quick Facts

Study Start:2020-08-07
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04246333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 12 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life
  2. * Infants with a birth weight \<1251g
  1. * First obtained pH \<7.0
  2. * 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))
  3. * Infants on hydrocortisone for hypotension prior to randomization
  4. * Infants with intrauterine growth restriction (IUGR) defined by birth weight ≤10th percentile for gestational age
  5. * 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
  6. * Infants with a history of intestinal perforation or NEC
  7. * Presence of gastrostomy tube
  8. * Infants who have not been initiated on any volume of enteral feeds by 10 days of life

Contacts and Locations

Study Contact

Noura Nickel, MD
CONTACT
727-767-4313
nnickel1@jh.edu

Principal Investigator

Noura Nickel, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins All Children's Hospital

Study Locations (Sites)

Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
United States

Collaborators and Investigators

Sponsor: Johns Hopkins All Children's Hospital

  • Noura Nickel, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins All Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2020-08-07
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Duodenal feeds
  • Transpyloric feeds
  • Bronchopulmonary Dysplasia
  • BPD
  • Premature infant
  • Neonate

Additional Relevant MeSH Terms

  • BPD - Bronchopulmonary Dysplasia
  • VLBW - Very Low Birth Weight Infant
  • Feeding Disorder Neonatal
  • Feeding; Difficult, Newborn
  • Premature Birth
  • Chronic Lung Disease of Prematurity