Preterm Infant Clinical Trial
Official title:
Routine Versus no Assessment of Gastric Residual Volumes in Very Low Birth Weight Infants Receiving Enteral Feeding Via Intermittent Feeding Tubes: A Randomized Controlled Trial.
NCT number | NCT04062851 |
Other study ID # | 1255832 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2019 |
Est. completion date | March 31, 2022 |
Verified date | April 2022 |
Source | AdventHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC. We hypothesize that not monitoring GRV in infants with birth weights < 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding. This is an unblinded randomized controlled trial where GRV will not be checked routinely in the intervention group.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 31, 2022 |
Est. primary completion date | July 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Month |
Eligibility | Inclusion Criteria: 1. Birth weight =1250g 2. Gestational age of < 33 weeks 3. Expected to receive feeds via gastric tubes Exclusion Criteria: 1. Death expected within 72 hours of birth 2. Major chromosomal or congenital anomaly 3. Major GI anomaly such as gastroschisis, spontaneous perforation etc. |
Country | Name | City | State |
---|---|---|---|
United States | AdventHealth | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
AdventHealth |
United States,
Li YF, Lin HC, Torrazza RM, Parker L, Talaga E, Neu J. Gastric residual evaluation in preterm neonates: a useful monitoring technique or a hindrance? Pediatr Neonatol. 2014 Oct;55(5):335-40. doi: 10.1016/j.pedneo.2014.02.008. Epub 2014 Aug 14. Review. — View Citation
Parker L, Torrazza RM, Li Y, Talaga E, Shuster J, Neu J. Aspiration and evaluation of gastric residuals in the neonatal intensive care unit: state of the science. J Perinat Neonatal Nurs. 2015 Jan-Mar;29(1):51-9; quiz E2. doi: 10.1097/JPN.0000000000000080 — View Citation
Torrazza RM, Parker LA, Li Y, Talaga E, Shuster J, Neu J. The value of routine evaluation of gastric residuals in very low birth weight infants. J Perinatol. 2015 Jan;35(1):57-60. doi: 10.1038/jp.2014.147. Epub 2014 Aug 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days to reach full enteral feeds | Days to reach enteral feeding volume of 120ml/kg/day | 1 month after enrollment | |
Secondary | Necrotizing enterocolitis | Stage 2 NEC and higher grade | Until hospital discharge, an average of 2-6 months | |
Secondary | weight gain | Weight gain velocity in gm/kg/d | 4 weeks chronological age and 36 weeks corrected gestation | |
Secondary | frequency of feeding interruptions | Number of timed feeds are withheld | Until full feeds are reached, usually between 2 weeks - 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04062513 -
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
|
N/A | |
Completed |
NCT03412578 -
Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants
|
N/A | |
Completed |
NCT03166722 -
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
|
N/A | |
Enrolling by invitation |
NCT03212547 -
The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
|
N/A | |
Completed |
NCT03931902 -
The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
|
N/A | |
Completed |
NCT03302000 -
Visual Stimulation of Preterm Infants
|
N/A | |
Completed |
NCT03731546 -
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
|
N/A | |
Completed |
NCT03104946 -
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
|
N/A | |
Completed |
NCT03704012 -
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
|
N/A | |
Suspended |
NCT03220282 -
The Milk, Growth and Microbiota Study
|
N/A | |
Active, not recruiting |
NCT03232931 -
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
|
N/A | |
Completed |
NCT03242057 -
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
|
N/A | |
Completed |
NCT04089540 -
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
|
N/A | |
Not yet recruiting |
NCT02528851 -
Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants
|
N/A | |
Completed |
NCT01959737 -
Delivery Room Skin-to-skin Study
|
N/A | |
Completed |
NCT03700463 -
Executive Functions and Preterm Children in 3 to 4 Year Old
|
||
Completed |
NCT02811432 -
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
|
N/A | |
Completed |
NCT03728764 -
Growth and Safety of a Two-stage Feeding System in Preterm Infants
|
N/A | |
Completed |
NCT04382976 -
The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
|
||
Completed |
NCT03748914 -
C-UCM and Cerebral Oxygenation and Perfusion
|
N/A |