Neonatology: Clinical Studies Open For Enrollment
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Eligibility
- Written informed consents and/or assents must be signed and dated by the participant’s parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
- Written informed consents and/or assents must be signed and dated by the participant’s birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
- Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
- Exclusion Criteria:
- Detectable major (or severe) congenital malformation identified before randomization.
- Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator’s opinion.
- Hypoglycemia at Baseline (blood glucose less than (<) 45 milligrams per deciliter [mg/dL] or 2.5 milli moles per liter [mmol/L]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
- Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator’s opinion.
- Any other condition or therapy that, in the investigator’s opinion, may pose a risk to the participant or interfere with the participant’s potential compliance with this protocol or interfere with interpretation of results.
- Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
- The participant or participant’s parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
- Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT03253263
Principal Investigator
Lance Parton, MD
Contact for Study Screening
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Eligibility
- Inborn at the study site’s hospital (i.e., not transferred from another hospital following delivery)
- Gestational age at birth of 26 through 33 weeks (260/7 through 336/7 weeks PMA)
- Birth weight appropriate for gestational age (AGA; weight 3rd to 97thpercentile on Fenton Growth Curve)
- Birth weight ≤ 2000 grams
- Post-natal age 1 to 24 hours at randomization
- On nCPAP or NIV for at least 30 minutes with respiratory severity score (RSS) = 1.4 – 2.0 to maintain SpO2 90-95%. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
- FiO2 ≥ 0.24 at randomization
- nCPAP or mean airway pressure (mPaw) ≥ 6 cm H2O at randomization
- Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization
- Exclusion Criteria:
- On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC; > 2 liters per minute [LPM]) at the time of randomization. These support systems are excluded because they cannot interface with the AeroFact system and/or do not provide accurate measurement of nCPAP level.
- Prior instillation of surfactant
- Premature rupture of membranes (PROM) occurring > 14 days before birth
- Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
- Pneumothorax
- Other etiologies of respiratory distress
- Enrollment in another interventional study with similar primary efficacy endpoints
- Apgar score at 5 minutes after birth of 0-3
- Prior cardiopulmonary resuscitation (CPR) or epinephrine
- Base Deficit > 15 mEq/L on most recent arterial blood gas (ABG; not capillary blood gas, venous blood gas, or cord gas) prior to randomization, if available. Note that ABG is not a required procedure prior to randomization.
- Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent AGB (not capillary blood gas, venous blood gas, or cord gas) prior to randomization, if available. Note that AGB is not a required procedure prior to randomization.
- Triplet or higher order multiple birth.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06776783
Principal Investigator
Edmund F La Gamma, MD
Contact for Study Screening