Clinical Trials Logo
  1. Home
  2. Premature Infant
  3. NCT03852641
  4. Details
NCT03852641 Clinical Trial

Feeding Premature Infants During Non-invasive Respiratory Support

Premature Infant Clinical Trial

Official title:
Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03852641
Other study ID # Feeding on NIPPV
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date June 2022

Study information
Verified date February 2019
Source Rambam Health Care Campus
Contact Liron Borenstein-Levin, MD
Phone 04-7774125
Email liron.boren@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Infants <1500gr, on non-invasive respiratory support

- Feeding>20 ml/kg/day

Exclusion Criteria:

- Major congenital malformations

- Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities

- Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Length of feeding
Feeds will be given via nasogastric tube over 15-30 min versus 2 hr

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxygenation instability as documented by oxygen saturation histograms before dischatge home at an average of 40 weeks gestation
Primary Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day before dischatge home at an average of 40 weeks gestation
Secondary Respiratory-length of respiratory support before dischatge home at an average of 40 weeks gestation
Secondary Incidence of Necrotising enterocolitis (NEC) as defined by the medical team before dischatge home at an average of 40 weeks gestation
See also
  Status Clinical Trial Phase
Terminated NCT02550054 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Completed NCT03827252 - Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
Active, not recruiting NCT03345069 - Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
Completed NCT04067206 - The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants N/A
Completed NCT03911674 - Effects of Oral Stimulation in Preterm Infants Phase 3
Completed NCT03324126 - Individualized Fortification of Breast Milk N/A
Completed NCT03704012 - Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) N/A
Active, not recruiting NCT03241082 - Ultrasound Assessment of BC in the NICU
Completed NCT03701906 - Effect of a Mixture of New Probiotic Strains in Preterm Infants N/A
Completed NCT02133716 - Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm Phase 4
Not yet recruiting NCT05543005 - Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants N/A
Active, not recruiting NCT03423914 - Efficacy of Expressive Writing in Mothers of Preterm Infants N/A
Recruiting NCT04648787 - A Study of Family-integrated Care for Reducing Uncertainty N/A
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Not yet recruiting NCT02534090 - Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy N/A
Not yet recruiting NCT02601872 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Recruiting NCT06212427 - Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs) N/A
Suspended NCT03939169 - The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) N/A
Completed NCT03683316 - Work of Breathing and Kangaroo Mother Care
Completed NCT03706586 - The Hilo Pilot -Trial to Assess Feasibility N/A