CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Condition: Neonatal Opioid Withdrawal Syndrome
MeSH terms: Syndrome; Substance Withdrawal Syndrome
Intervention: CHF6563; Morphine; CHF6563 matched placebo; Morphine matched placebo
Intervention description: Sublingual CHF6563 administration at starting dose of 10 µg/kg q8; Oral morphine administration at starting dose of 0.07 mg/kg q4; Sublingual CHF6563 matched placebo administration; Oral morphine matched placebo administration
Intervention MeSH terms: Morphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: double blind, double-dummy
Enrollment: 7.0
Sex: All
Maximum age: 7 Days
Healthy volunteers: No

Summary:

      A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to
      evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid
      Withdrawal Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent obtained by parents/legal representative(according to local
             regulation) prior to or after birth.

          2. Birth weight ≥ 3rd centile for gestational age (GA), according to the Centers for
             Disease Control and Prevention (CDC) growth chart

          3. Gestational age ≥ 36 weeks

          4. Exposure to opioids during the last month of fetal life

          5. Signs of neonatal opioid withdrawal syndrome requiring treatment, and the sum of 3
             consecutive FNAST scores is ≥ 24 or a single score ≥ 12

        Exclusion Criteria:

          1. Familial history of prolonged QTc syndrome

          2. Major congenital malformations or evidence of congenital infection

          3. Signs of fetal alcohol spectrum disorders

          4. Maternal alcohol abuse, defined as average of 3 or more drinks per week in the last 30
             days

          5. Medical illness at the time of randomization, including but not exclusively:

               1. Neonatal hypoglycemia requiring intravenous glucose therapy

               2. Neonatal respiratory illness requiring non-invasive or invasive respiratory
                  support

               3. Neonatal encephalopathy (including hypoxic ischemic encephalopathy or seizures

               4. Severe hyperbilirubinemia-bilirubin at or above the exchange transfusion
                  threshold as defined by the American Academy of Pediatrics (AAP)

               5. Severe elevation of serum aminotransferases (more than twice the upper limit of
                  the age appropriate aminotransferases reference range of the investigational
                  site).

               6. Proven or suspected early onset neonatal infection which will require more than
                  48 hours treatment with antibiotics

          6. Unable to tolerate an oral or sublingual medication

          7. Need for medications forbidden in this study protocol

          8. Any condition that, in the opinion of the Investigator, would place the neonate at
             undue risk

          9. Participation in another clinical trial of any medicinal product, placebo,
             experimental medical device or biological substance conducted under the provisions of
             a protocol on the same therapeutic target. The participation in studies involving
             diagnostic devices or treatments for conditions other than NOWS and Neonatal
             abstinence syndrome (NAS) may be permitted following an agreement with the Sponsor.
             Non-interventional observational studies are allowed