Early Versus Late Caffeine for ELBW Newborns

NCT02524249 | Terminated DMC

• 1 other identifier: 1506014098
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the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.

Conditions

Bronchopulmonary Dysplasia; Apnea of Prematurity

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of death and bronchopulmonary dysplasia

  36 weeks post menstrual age

Study Arms (2)

Early caffeine group

ACTIVE COMPARATOR

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.

Drug: Caffeine

Late caffeine group

PLACEBO COMPARATOR

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.

Drug: Placebo (dextrose)

Interventions

Caffeine DRUG

Early caffeine group

Placebo (dextrose) DRUG

Late caffeine group

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wayne State University: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Hutzel Women's Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Apnea

Interventions

Caffeine; Glucose

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Nitin S Chouthai, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 2, 2022

Record last verified: 2019-06

Locations

US (1)