• Current Studies (May 2017)
    1. DOVE — Drager Oscillatory Ventilation Evaluation
    2. Sildenafil for PPHN
    3. HIP — Hernia in Premies
    4. Furosemide — Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia
    5. TCOM — Transcutaneous Monitoring in Preterm Infants
    6. WOB Study — Evaluation of Work of Breathing in NAVA vs NIPPV
    7. Cubist — Pharmacokinetics of Ceftolozance/Tazobactam
    8. Remodulin — Intravenous Remodulin (Treprostinil) as Add-On Therapy for the Treatment of PPHN
    9. AEROSURF — Aerosolized Surfactant for Treatment of RDS
  • Closed to new enrollment (May 2017)
    1. PENUT Trial — Preterm Epo Neuroprotection
    2. SCAMP — Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections (SCAMP)
    3. IBT — A Trial of Lactobacillus reuteri (A Probiotic) in Preterm Infants
  • Pending Studies (Open for enrollment soon)
    1. DINE — Developmental Impact of NICU Exposure
    2. INO Database — Use of iNO in preterm infants
  • Pending Studies (Awaiting site approval)
    1. Cannabadiol for HIE
    2. Mecasermin rinfabate — SHP607 (mecasermin rinfabate) for prevention of BPD

Current Research Studies (May 2017)

DOVE — Drager Oscillatory Ventilation Evaluation

Sponsor: Drager Inc.

Location: UAMS and ACH

Inclusion Criteria:

  • Gestational Age at birth: 23 – 30 weeks
  • Birth weight: 400 – 1200 grams
  • Chronologic Age: less than 96 hours
  • 5-minute Apgar > 3
  • Clinician would like HFOV

Exclusion Criteria:

  • Already ventilated ≥ 96 hours
  • Major respiratory or cardiac anomalies
  • Pre-existing air leak
  • Known grade III/IV IVH

Contact any of the following:

  • Courtney 631-682-0812
  • Andrea Ross: 501-364-3122

Sildenafil for PPHN

Sponsor: Pfizer Labs

Location: ACH

Inclusion Criteria:

  • Gestational Age at birth: 34 weeks or greater
  • Chronologic Age: less than 96 hours
  • Diagnosis of PPHN on iNO

Exclusion Criteria:

  • Life-threatening anomalies
  • Diaphragmatic hernia
  • 5-minute Apgar Score < 5

Contact either:

  • Allen Harrison: 501-364-7192 or 404-734-3777 (text preferred) or pager 405-0829
  • Courtney: 631-682-0812 (text okay)

HIP — Hernia in Premies

Sponsor: Vanderbilt University

Location: ACH and UAMS (for recruitment)

Inclusion Criteria:

  • Gestational Age at birth: less than 37 weeks
  • The presence of an inguinal hernia

Exclusion Criteria:

  • Major anomalies
  • Simultaneous other surgery planned for hernia repair

Contact any of the following:

  • Dassinger:501-364-2943
  • Kathy Hummel:501-364-2715

Furosemide — Safety in Premature Infants at Risk of Bronchopulmonary Dysplasia

Sponsor: NIH/NICHD and the Pediatric Trials Network

Location: ACH

Inclusion Criteria:

  • Gestational Age at birth: less than 29 weeks
  • Chronologic age: 7–28 days
  • On nCPAP, NIPPV, NC, or mechanical ventilation

Exclusion Criteria:

  • Previous diuretics
  • Significant PDA
  • Certain abnormal lab at admission

Contact any of the following:

  • Andrea Ross: 501-364-3122
  • Courtney: 631-682-0812

TCOM Study — Transcutaneous Monitoring in Preterm InFANTS

Sponsor: CUMG

Location: UAMS (primarily) and ACH

Inclusion Criteria:

  • Preterm infants 1-2 kg
  • Umbilical artery catheter
  • Clinically stable with Hct > 35%

Exclusion Criteria:

  • On pressors
  • Clinically unstable or anemic

Contact any of the following:

  • Jessica Farrell (PI): 870-550-3514
  • Michelle Jones: 225-274-6410
  • David Matlock: 318-458-9097
  • Sherry Courtney: 631-682-0812

WOB Study — Evaluation of Work of Breathing in NAVA vs NIPPV

Location: ACH

Inclusion Criteria:

  • Preterm infants 1-2 kg
  • On NIPPV or NIV-NAVA
  • Clinically stable with FiO2 < 40%

Exclusion Criteria:

  • Major anomalies
  • Clinically unstable

Contact:

  • David Matlock: 318-458-9097
  • Sherry Courtney: 631-682-0812
  • Michelle Jones: 225-274-6410

Cubist Study — Pharmacokinetics of Ceftolozance/Tazobactam

Sponsor: Cubist Pharmaceuticals

Location: ACH

Inclusion Criteria:

  • Chronological age: ≥ 7 days of life
  • Receiving standard of care antibiotic therapy for suspected or diagnosed Gram-negative infection or for peri-operative prophylaxis

Exclusion Criteria:

  • Clinically unstable
  • Imminent (within 24 hours) need for blood transfusion
  • Recent (within 24 hours) receipt of Zosyn

Contact any of the following:

  • Romero:501-364-1416
  • Patricia Brady:501-364-1544

Remodulin — Intravenous Remodulin (Treprostinil) as Add-On Therapy for the Treatment of PPHN

Sponsor: United Therapeutics

Location: ACH

Inclusion Criteria:

  • Gestational age ≥ 34 weeks and weight ≥ 2 kg
  • Chronologic Age: ≤ 14 days
  • Diagnosis of PPHN and currently requiring ventilator support
  • Two consecutive OIs of 15 or greater separated by at least 30 minutes, after receiving iNo for at least 3 hours

Exclusion Criteria:

  • Significant congenital heart disease (CHD)
  • Uncontrolled coagulopathy and/or untreated thrombocytopenia
  • History of severe (Grade 3 or 4) intracranial hemorrhage

Contact any of the following:

  • Allen Harrison: 501-364-7192 or 404-734-3777 (text preferred) or pager 405-0829
  • Courtney: 631-682-0812

AEROSURF — Aerosolized Surfactant for Treatment of RDS

Sponsor: Discovery Labs

Location: UAMS

Inclusion Criteria:

  • Gestational Age: 26 to 32 weeks
  • On NCPAP within 90 minutes after birth and requiring FiO2 ≥ 0.25
  • Chest radiograph consistent with RDS

Exclusion Criteria:

  • Recurrent episodes of apnea requiring positive pressure ventilation (PPV)
  • A 5-minute Apgar Score < 5
  • Clinically unstable

Contact any of the following:

  • Betty Proffitt: 501-658-6241
  • Weiss: 619-302-7209
  • Walter: 501-920-8080
  • Courtney: 631-682-0812

Pending Studies (Open for enrollment soon)

DINE — Developmental Impact of NICU Exposure

INO Database — Use of iNO in preterm infants

Pending Studies (Awaiting site approval)

Cannabadiol for HIE

Mecasermin rinfabate — SHP607 (mecasermin rinfabate) for prevention of BPD

Closed to New Enrollment (May 2017)

PENUT Trial — Preterm Epo Neuroprotection

Sponsor: NIH/NINDS

Location: UAMS and ACH

All PENUT patients will be followed through two years corrected age
Followup is in progress

SCAMP — Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections (SCAMP)

Sponsor: NIH/NICHD and the Pediatric Trials Network

Location: ACH

Data analysis is in progress

IBT — A Trial of Lactobacillus reuteri (A Probiotic) in Preterm Infants

Sponsor: Infant Bacterial Therapeutics

Location: UAMS and ACH

Data analysis is in progress

Last Updated 2017-05-16 11:00 (Maintained by Dr. Courtney and Donnal Walter)