Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
Condition: Prematurity; Respiratory Insufficiency; Pulmonary Hypertension; Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hypertension, Pulmonary; Respiratory Insufficiency
Intervention: Aerosolized Normal Saline; Inhaled PGE1
Intervention description: Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.; Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.
Intervention MeSH terms: Alprostadil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Maximum age: 7 Days
Healthy volunteers: No

Summary:

      This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in
      Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume
      sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate
      the feasibility and safety of prolonged IPGE1 administration and determination of optimal
      dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over
      a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of
      IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale
      randomized controlled trial will be planned.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age less than or equal to 34 weeks

          -  Postnatal age less than or equal to 7 days (168 hours).

          -  Assisted ventilation for hypoxemic respiratory failure.

          -  Diagnosis of NHRF including perinatal aspiration syndrome (meconium, blood, or
             amniotic fluid), suspected/proven pneumonia/sepsis, respiratory distress syndrome,
             idiopathic persistent pulmonary hypertension of the newborn (PPHN) or suspected
             pulmonary hypoplasia.

          -  Receiving INO for at least 1 hour and not >72 hours.

          -  Oxygenation Index (OI ) ≥ 15 on any 2 arterial blood gases 15 minutes to 12 hours
             apart while on INO.

          -  An indwelling arterial line is present

        Exclusion Criteria:

          -  Any infant in whom a decision has been made not to provide full treatment (e.g.
             chromosomal anomalies, severe birth asphyxia).

          -  Known structural congenital heart disease except patent ductus arteriosus and
             atrial/ventricular level shunts.

          -  Congenital diaphragmatic hernia.

          -  Thrombocytopenia unresponsive to platelet transfusion.

          -  Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial.