Table 3 Studies of pharmacologic treatment for neonatal abstinence syndrome
From: Review of the assessment and management of neonatal abstinence syndrome
Reference | Design | Purpose | Comparison (Index vs. Reference) | Assessment measure | Primary outcome | Results |
|---|---|---|---|---|---|---|
Jackson, 2004[50] | Double-blind RCT | Efficacy of opioid vs. phenobarbitone as first-line therapy | Morphine (n = 41) Phenobarbitone (n = 34) | Lipsitz | Mean length of Rx | 8 vs. 12 days* (unadjusted) |
Langenfeld, 2005[51] | Randomized Trial, Blinding Not Specified | Compare tincture of opium to oral morphine | Morphine (n = 17) | Finnegan | Mean length of Rx | 29.8 vs. 26.9 days |
|  |  | Tincture of Opium (n = 16) |  | Mean LOS | 37.5 vs. 32.4 days | |
Kraft, 2008[52] | Phase I, Randomized, Open Label, Active Control | Feasibility and safety of buprenorphine in Rx of NAS | Buprenorphine (n = 13) | Modified Finnegan | Mean length of Rx | 22 (SD 12) vs. 32 (SD 16) days |
|  |  | Neonatal opium solution (n = 13) |  | Mean LOS | 27 (SD 11) vs. 38 (SD 13) days | |
Kraft, 2011[53] | Phase I, Randomized, Open Label, Active Control | Feasibility and safety of buprenorphine | Buprenorphine (n = 12) | Modified Finnegan | Mean length of Rx | 23 vs. 38 days* |
|  |  | Morphine (n = 12) |  | Mean LOS | 23 vs. 42 days | |
Coyle, 2002[54] | Partially Randomized, Controlled Trial | Assess whether Rx with DTO + phenobarbital vs. DTO alone is better | DTO + phenobarbital (n = 10) | Finnegan | Finnegan Scores | Infants in placebo group, spent more time with FS > 7 * |
|  |  | DTO + placebo (n = 10) |  |  | Infants in phenobarbital group spent more time with FS < 5* | |
| Â | Â | Â | Â | Mean LOS | Mean: 38 vs. 79 days* | |
Agthe, 2009[55] | Randomized, Double-Blinded Controlled Trial | To assess use of clonidine as an adjunct therapy to opioids to manage NAS | Clonidine (n = 40) | Modified Finnegan | Mean length of Rx | 11 (95% CI 8–15) vs. 15 (95% CI 12–17) days |
|  |  | Placebo (n = 40) |  |  |  | |
Surran, 2013[56] | Randomized, Nonblinded Controlled Trial | Clonidine versus phenobarbital to reduce # days of Rx with morphine sulfate | Phenobarbital (n = 34) | Modified Finnegan | Length of Rx with morphine sulfate | B = -4.6 days (95% CI 0.3–8.9)* |
|  |  | Clonidine (n = 32) |  |  |  |