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Early Versus Late Caffeine for ELBW Newborns

Primary Purpose

Bronchopulmonary Dysplasia, Apnea of Prematurity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine
Placebo (dextrose)
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia

Eligibility Criteria

undefined - 4 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newborns with birth weight less than or equal to 1000grams and less than 28 weeks of gestation are included if intubated by 12 hours of life

Exclusion Criteria:

  • newborns with known congenital malformation
  • newborns whose parents refuse consent for the study
  • newborns who are on high frequency ventilation and/or receiving more than 80% oxygen at 12 hours of age
  • newborns deemed non-viable by the clinical team (defined as those neonates born at <24 weeks gestation and whose parents are offered withdrawal of support or do not resuscitate by clinical team for severity of cardiorespiratory illness at or before 12 hours of age)
  • newborns diagnosed with congenital heart disease within the first 12 hours of life (presence of a ventricular septum defect and a patent ductus arteriosus is not an exclusion criteria)

Sites / Locations

  • Hutzel Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Early caffeine group

Late caffeine group

Arm Description

55 newborns will be randomized to receive caffeine within 24 hours of life. They will receive 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds.

55 newborns will be randomized to receive a placebo (dextrose) in the first 24 hours of life. They will receive a 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give the placebo orally is the newborn tolerates >75% of fluid goals by feeds.

Outcomes

Primary Outcome Measures

Cumulative incidence of death and bronchopulmonary dysplasia

Secondary Outcome Measures

Full Information

First Posted
August 12, 2015
Last Updated
April 25, 2022
Sponsor
Wayne State University
Collaborators
The Gerber Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02524249
Brief Title
Early Versus Late Caffeine for ELBW Newborns
Official Title
A Randomized Double Blind Controlled Trial of Early Versus Late Caffeine for Extremely Low Birth Weight Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Frequent protocol violations
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
The Gerber Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns. Retrospective design can be biased as newborns with mild lung disease may have received caffeine early for extubation. There are several studies on pharmacodynamics and pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine levels and BPD outcome is deficient. Primary objective of this study is to test the hypothesis that early caffeine given within 24 hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns. This study will also test an additional hypothesis that higher caffeine dosage and caffeine levels are associated with decreased mortality and postnatal morbidities in studied newborns.
Detailed Description
Parents will be approached either prenatally for an impending delivery of ELBW newborn or within 16 hours of birth. 90 newborns will be randomized to receive early caffeine within 24 hours of life (the "study drug") and 90 newborns will receive a placebo. Either the early caffeine (the "study drug") or placebo will be continued throughout the first 15 days of life. Newborns in the early caffeine group will receive an IV bolus of 20mg/kg followed by IV or PO 5mg/kg daily for 14 days. The clinical team can choose to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds. The clinical and research teams will be blinded; neither will know whether the newborn is receiving early caffeine or placebo. The clinical team will be allowed to use open labeled caffeine as deemed medically necessary after 24 hours of receiving either the early caffeine or placebo. Often this clinical need would be at the time of extubation (peri-extubation) and comprises the "late" caffeine group, which is also the placebo group. Perinatal and postnatal clinical characteristics will be prospectively collected. Clinical team may choose to hold study drug if newborns are placed on high frequency ventilation or if they need sedation drips for surgical procedures. Two blood samples will be collected one at day 7 and one at day 14 for caffeine levels. Data safety monitoring committee will be review mortality and morbidity in each group on a quarterly basis or after recruitment of every 30 newborns whichever happens earlier.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Apnea of Prematurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early caffeine group
Arm Type
Active Comparator
Arm Description
55 newborns will be randomized to receive caffeine within 24 hours of life. They will receive 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds.
Arm Title
Late caffeine group
Arm Type
Placebo Comparator
Arm Description
55 newborns will be randomized to receive a placebo (dextrose) in the first 24 hours of life. They will receive a 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give the placebo orally is the newborn tolerates >75% of fluid goals by feeds.
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Type
Drug
Intervention Name(s)
Placebo (dextrose)
Primary Outcome Measure Information:
Title
Cumulative incidence of death and bronchopulmonary dysplasia
Time Frame
36 weeks post menstrual age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: newborns with birth weight less than or equal to 1000grams and less than 28 weeks of gestation are included if intubated by 12 hours of life Exclusion Criteria: newborns with known congenital malformation newborns whose parents refuse consent for the study newborns who are on high frequency ventilation and/or receiving more than 80% oxygen at 12 hours of age newborns deemed non-viable by the clinical team (defined as those neonates born at <24 weeks gestation and whose parents are offered withdrawal of support or do not resuscitate by clinical team for severity of cardiorespiratory illness at or before 12 hours of age) newborns diagnosed with congenital heart disease within the first 12 hours of life (presence of a ventricular septum defect and a patent ductus arteriosus is not an exclusion criteria)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin S Chouthai, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hutzel Women's Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

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Early Versus Late Caffeine for ELBW Newborns

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