Modified Finnegan Scoring Research Articles

Lessons learned from a comparison of evidence‐based research in pregnant opioid‐dependent women

Lessons learned in research and treatment of opioid dependence demonstrate the need to include pregnant women in clinical trials. Two double-blind, double-dummy, randomized controlled trials (Pilot study, European sample(†) of MOTHER-trial) comparing buprenorphine and methadone in opioid-dependent pregnant women were conducted. In both studies, participants received voucher-based incentives for attendance and completion of study assessments. In the MOTHER trial, participants additionally received escalating voucher incentives for drug-free urine samples. Neonatal abstinence syndrome was treated with oral morphine solution based on standardized modified Finnegan scores. After a mean treatment period of 13.79 weeks in the Pilot study (PS, n = 18) and 20.78 weeks in the MOTHER-trial (MT, n = 41), respectively (p < 0.001), PS patients delivered at mean doses of 14.00 mg buprenorphine/52.50 mg methadone and MT participants at 13.44 mg buprenorphine/63.68 mg methadone. Nonsignificant differences regarding dropout rates were found (22% in PS versus 10% in MT), but dropout was significantly earlier in the MT (p = 0.013). Significantly higher rates of concomitant consumption of opioids and benzodiazepines occurred in the PS compared with the MT (p < 0.001), however, with no significant differences in neonatal data between both settings. Early treatment enrolment combined with contingency management contributes to reduced illicit drug use throughout pregnancy, surprisingly without influencing neonatal outcome parameters.

The Impact of Infant Feeding Method on Neonatal Abstinence Scores of Methadone-Exposed Infants

To determine whether neonatal abstinence scores of infants exposed to methadone in utero differed by infant feeding method. A retrospective chart review. Twenty-eight term infants that were exposed to methadone in utero and exhibited symptoms of neonatal abstinence syndrome (NAS) prior to hospital discharge were included into the study. The sample was further divided by self-selected infant feeding method including (1) predominately breastfed (n = 8), combination fed (n = 11) or predominately formula fed (n = 9). Data were extracted by two independent researchers from both the mother's and infant's chart. This included variables such as NAS scores, NAS treatment, infant feeding method and baseline demographic information. NAS scores were assessed by Registered Nurses according to hospital protocol using a Modified Finnegan Scoring Tool. A non-parametric Kruskal-Wallis one way analysis of variance based on ranks revealed statistically significant differences in the number of NAS scores recorded (P = 0.001), magnitude (P < 0.0001) and area score (P = 0.04) by infant feeding method. In particular, infants who were predominantly breastfed had significantly fewer NAS scores done and lower mean scores suggesting decreased severity and duration of NAS symptoms when compared to infants who were combination fed or predominately formula fed. Breastfeeding may offer enhanced benefits for infants who have been exposed to methadone in utero. As such, in the absence of contraindications, mothers in methadone maintenance programs should be encouraged and supported to breastfeed their infants.

1153 Impact of Babies Born to Substance Misusing Mothers on a Regional Maternity Hospital in the West Midlands

Background: The incidence of maternal drug misuse is increasing. A screening study found that 16% of pregnant women in the UK have misused drugs or illicit substances.1 The babies born to substance misusing mothers have additional impact on the maternity and neonatal services. Aim: To review the impact of babies born to substance misusing mothers (SMM). Methods: A retrospective audit of the care provided to infants born to SMM at a regional maternity hospital in UK over 12 months (01/04/09-31/03/10). Results: In the last 12 months, 38 babies born to SMM were admitted to the transitional care and 3 were admitted to the neonatal unit because of their prematurity. 31 mothers were on the methadone programme. Their median gestation age was 38 weeks with a median birth weight of 2770 grams. All babies were observed using the modified Finnegan score. 8/41(19%) needed treatment with morphine. The overall median length of stay (LOS) was 9 days. In those infants who did not need treatment, median LOS was 7.5 days. 16/41 (39%) had safeguarding issues with 12 infants placed in foster care and 3 infants placed in a mother and baby residential unit. Conclusion: Babies born to SMM take up significant time, input and resources from the neonatal and social services. They have significantly longer LOS even when they do not need treatment. In view of the increasing prevalence of SMM, this needs to be taken into consideration when allocating resources.

Clonidine as an Adjunct Therapy to Opioids for Neonatal Abstinence Syndrome: A Randomized, Controlled Trial

To determine if oral clonidine would reduce the duration of opioid detoxification for neonatal abstinence syndrome. Infants with intrauterine exposure to methadone or heroin and neonatal abstinence syndrome (2 consecutive modified Finnegan scores of > or =9) were enrolled at 2 hospitals during 2002-2005 and followed until final hospital discharge. All enrolled infants (80) received oral diluted tincture of opium according to a standardized algorithm and were randomly assigned to receive oral clonidine (1 microg/kg every 4 hours) (40 infants) or placebo (40 infants). Primary outcome was duration of opioid therapy. Secondary outcomes included the amount of opium required to control symptoms, number of treatment failures, and differences in blood pressure, heart rate, and oxygen saturation. The median length of therapy was 27% shorter in the clonidine group (11 [95% confidence interval: 8-15 days]) than in the placebo group (15 days [95% confidence interval: 12-17 days]). In the clonidine group, 7 infants required restarting opium after initial discontinuation versus none in the placebo group, with the total length of treatment/observation remaining significantly less in the clonidine group. Higher dosages of opium were required by 40% of the infants in the placebo group versus 20% in the clonidine group. Treatment failures occurred in 12.5% of the infants in the placebo group versus none in the clonidine group. Hypertension, hypotension, bradycardia, or desaturations did not occur in either group. Three infants in the clonidine group died as a result of myocarditis, sudden infant death syndrome, and homicide, all after hospital discharge and before 6 months of age. In this randomized, double-blind trial, adding clonidine to standard opioid therapy for detoxification from in utero exposure to methadone or heroin reduced the duration of pharmacotherapy for neonatal abstinence without causing short-term adverse cardiovascular outcomes. A larger trial is indicated to determine long-term safety.

Benign neonatal sleep myoclonus in newborn infants of opioid dependent mothers

The aim of our study was to evaluate the incidence, duration and risk factors for benign neonatal sleep myoclonus (BNSM) in infants with neonatal abstinence syndrome (NAS) treated with opioids or sedatives, compared with control infants. This is a single centre observational case control study. Seventy-eight near term and term infants with neonatal opiate abstinence syndrome confirmed by meconium analysis were included. Exclusion criteria were cerebral malformation, intracranial haemorrhage and perinatal asphyxia. The babies were assessed eight hourly with a modified Finnegan score that included sleep myoclonus. Seventy-eight infants not exposed to opiates during pregnancy, hospitalized for at least 14 days and matched for gestational age were used as controls. The median gestational age was 38 (1)/(7) (95% CI: 35 (3)/(7)-41 (2)/(7)) weeks, birth weight 2730 (95% CI: 1890-3600) g, umbilical artery pH 7.25 (CI 7.10-7.37) and Apgar score at 5 minutes 9 (95% CI: 7-10). The control infants did not differ in these characteristics. Sleep myoclonus was diagnosed in 52 (67%) of the infants with NAS and 2 (2.6%) of the controls (OR 26 [95% CI: 7-223], p < 0.001). Myoclonus appeared as early as day 2 and as late as day 56 of life (median day 6) and lasted for 1 to 93 days (median 13 days). All infants had serum glucose > 2.5 mmol/L at first occurrence. The neurological examinations as well as cerebral ultrasound scans were normal. An electroencephalogram (EEG) carried out in 18 infants showed no signs of epileptic activity. BNSM has a high incidence in infants with NAS. The diagnosis can be made clinically. In the absence of other neurological symptoms further investigations such as EEG are not necessary and anticonvulsive treatment is not indicated.

Sublingual Buprenorphine for Treatment of Neonatal Abstinence Syndrome: A Randomized Trial

In utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial mu-opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered. We conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 mug/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system. Sublingual buprenorphine was largely effective in controlling neonatal abstinence syndrome. Greater than 98% of plasma concentrations ranged from undetectable to approximately 0.60 ng/mL, which is less than needed to control abstinence symptoms in adults. The ratio of buprenorphine to norbuprenorphine was larger than that seen in adults, suggesting a relative impairment of N-dealkylation. Three infants who received buprenorphine and 1 infant who received standard of care reached protocol-specified maximum doses and required adjuvant therapy with phenobarbital. The mean length of treatment for those in the neonatal-opium-solution group was 32 compared with 22 days for the buprenorphine group. The mean length of stay for the neonatal-opium-solution group was 38 days compared with 27 days for those in the buprenorphine group. Treatment with buprenorphine was well tolerated. Buprenorphine administered via the sublingual route is feasible and apparently safe and may represent a novel treatment for neonatal abstinence syndrome.