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Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission

P

Pediatrix

Status

Terminated

Conditions

Hypoglycemia
Neonatal Hypoglycemia

Study type

Observational

Funder types

Other

Identifiers

NCT04085978
501938027

Details and patient eligibility

About

Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.

Full description

This project will evaluate various aspects of infants with hypoglycemia admitted to the Neonatal Intensive Care Unit (NICU) pre- and post- implementation of a hospital-wide hypoglycemia protocol with oral glucose gel. Subjects will be matched by gestational age (GA), birth weight rounded to the nearest half kilogram, ethnicity, gender, maternal age, maternal diabetes status, maternal parity, maternal ethnicity, and mode of delivery. Retrospective data will be reviewed including neonatal and maternal demographics and NICU medical course data. The results of this study can inform intended and unintended consequences of the instituted protocol.

Enrollment

400 patients

Sex

All

Ages

34+ weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 and January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol.

Exclusion criteria

  • Neonates <34 weeks gestational age or with birth weight less than 2000 grams.
  • Infants with serious congenital malformation
  • Infants with a terminal disorder.

Trial design

400 participants in 2 patient groups

Pre implementation of hypoglycemia protocol with glucose gel
Description:
All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 who qualify for hypoglycemia protocol
Post implementation of hypoglycemia protocol with glucose gel
Description:
All neonates born at Banner University Hospital during January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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