MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine

NCT00809055 | Completed Phase 4 Results DMC

• 3 other identifiers: 08-0849R01HD057098-01HRPO 08-0849
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.

Conditions

Apnea of Prematurity; Intraventricular Hemorrhage; Brain Injury

Outcome Measures

Primary Outcomes (1)

• White Matter Microstructural Maturation

  Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.

  Participants were followed for the duration of hospital stay, an average of 12 weeks

Secondary Outcomes (9)

• Mortality Rates

  Participants were followed for the duration of hospital stay, an average of 12 weeks

• Cerebellar Hemorrhage

  Participants were followed for the duration of hospital stay, an average of 12 weeks

• Length of Time Requiring Invasive Respiratory Support

  Participants were followed for the duration of hospital stay, an average of 12 weeks

• Rates of Chronic Lung Disease

  Participants were followed for the duration of hospital stay, an average of 12 weeks

• Rates of Necrotizing Enterocolitis

  Participants were followed for the duration of hospital stay, an average of 12 weeks

Study Arms (2)

High dose caffeine

EXPERIMENTAL

Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.

Drug: Caffeine citrate

Standard dose caffeine

ACTIVE COMPARATOR

Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.

Drug: Caffeine citrate

Interventions

Caffeine citrate DRUG

Caffeine to be administered as outlined to compare efficacy of different dosages.

Also known as: Cafcit

High dose caffeine; Standard dose caffeine

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants from 24 to 30 weeks completed PMA admitted to the neonatal intensive care unit (NICU) at St. Louis Children's Hospital. The estimated post menstrual age will be provided by the obstetrical records and compared with a Dubowitz exam at admission. The provided PMA will be used unless the Dubowitz exam has a discrepancy of greater or equal to 2 weeks, where then the Dubowitz age will be used.
• Infants must be recruited within the first 24 hours of life.

You may not qualify if:

• Infants over 30 weeks gestation.
• Infants who are moribund with severe sepsis, in respiratory failure, or have severe brain injury present in the first 24 hours of life. This would be defined as physiologic instability requiring \>80% FiO2 for 6 hours and/or more than 2 inotropic drugs (excluding hydrocortisone), or in the attending or recruiting physicians' opinion the infant is likely to die within 24 hours or would not tolerate any handling for the protocol.
• Infants must not have received any doses of caffeine citrate prior to enrollment.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Apnea; Brain Injuries

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Terrie Inder
• Organization: Brigham and Women's Hospital

tinder@partners.org

617-525-6650

Study Officials

• Terrie Inder, MBChB, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2015
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)