LOWELL GENERAL HOSPITAL



LOWELL GENERAL HOSPITAL HOSPITAL POLICY AND PROCEDURE MANUALPURPOSE: To provide guidelines for the evaluation and management of mother/infant dyad affected by substance use disorder or engaged in the prescribed use of an opioid medication including: Illicit substance use (cocaine, opioid, phencyclidine, methamphetamine, amphetamines, barbiturates), inappropriate use of controlled substances, and use of substances not recommended in pregnancy (alcohol, cannabinoids)Medically prescribed synthetic opioids such as methadone and buprenorphine for management of maternal opioid dependencePrescribed maternal opiates for other diagnoses excluding opioid dependence.II.SCOPE: RN, LPN, Obstetrical and Pediatric Care Providers, Continuity of Care (COC)III.DEFINITIONS:NNP – Neonatal Nurse PractitionerCNM – Certified Nurse MidwifeNMS – Neonatal Morphine SolutionNAS – Neonatal Abstinence SyndromeSEN- Substance Exposed NewbornESC- Eating, Sleeping, ConsolingIV.POLICY: Introduction:A substance exposed newborn (SEN) is defined as a newborn with in utero exposure to illicit substances, inappropriately used prescribed substances, or medically prescribed opioids places the newborn at risk for withdrawal postnatally.This guideline was written for the patient population followed at Lowell General Hospital. This document is a guideline and should not replace the clinical judgment of the attending physician and health care team.Breastfeeding: Please reference Breastfeeding of the Newborn Policy (provide link)PROCEDURE:Evaluation and Management of the Substance Exposed Newborn (SEN)Complete history and physical examination: Careful maternal substance-use history by Obstetrical Care Provider should be performed to ensure proper monitoring and pharmacologic treatment of the infant (if needed). Concerns should be conveyed to Pediatric Care Provider. Pediatric care providers responsible for verifying history with mother, performing thorough physical examination on infant, and determining if infant requires extended hospitalization Confirm maternal prenatal test results: Hepatitis B and C, Human Immunodeficiency Virus (HIV), Syphilis (RPR), Gonorrhea, Chlamydia, Herpes simplex virus (HSV) and treat accordinglyConsider other potential causes of jitteriness, irritability, and poor feedingDo not give naloxone (Narcan) to infants exposed to opioids (including methadone, buprenorphine) in utero as this may precipitate immediate withdrawal or seizures.Toxicology ScreeningPrinciples of toxicology screening:Consider obtaining toxicology screening on (both mother and?) infant when maternal and /or newborn risk indicators, which are listed below, are present in order to guide clinical management of the rm parent(s) of the clinical indications for toxicology screening and the reason for the screening. The screening protocol below is based on high risk behavior associated with perinatal substance use. Testing for substances of use should always ensure the mother’s right to privacy and still allow physicians to optimize medical care to both mother and infant. If the mother refuses testing on herself, testing of the newborn may still occur if it is medically necessary and /or maternal or infant risk indicators are present. Documentation of clinical indicators and consent should be noted in electronic medical record.Results of the test should be communicated to the mother and health care team.According to federal law (The Child Abuse Prevention and Treatment Act), healthcare providers are required to report all infants born and identified as affected by illegal substance use, prescribed substance use or experiencing withdrawal symptoms resulting from prenatal illegal drug exposure. The presence of other risk factors or information combined with a positive toxicology screen for an illegal substance will require that a report of child abuse or neglect be made to DCF (The Department of Children and Families) in any given case. Continuity of Care in conjunction with members of the health care team will assess on an individual basis for risk factors of abuse or neglect and notify DCF as necessary. Maternal Risk IndicatorsMaternal clinical characteristics that suggest a need for toxicology screening of the pregnant women and her newborn at the time of admission are listed below:History of illicit substance use or treatment for substance use disorder in pregnancyMedical symptoms of withdrawalContinuous use of a prescribed opioid for six weeks or longer during the pregnancy No prenatal carePatients first prenatal visit was after 20 weeks gestationErratic prenatal care as determined by Obstetrical Care Provider or Pediatric Care ProviderUnusual behavior that can potentially affect the mother’s care of the infantWomen with perinatal complications listed below that can be associated with substance use/abuse and who have a history of substance use or concerns by behavior or history as determined by the Obstetrical or Pediatric Care ProviderPlacental abruption of unknown etiology Precipitous labor (less than 3 hours – including verbalizing home labor) – May not be indicated with multiparous patients Current fetal demise Unexplained hypertensive episodes or other cardiovascular eventsExtramural singleton delivery (outside hospital), Newborn Risk IndicatorsAdditional possible indicators for obtaining urine and meconium toxicology screens on the newborn include: : Any of above listed maternal indicatorsMaternal toxicology screen positive for illicit substances or for controlled substances not prescribed to the mother Signs of Neonatal Abstinence SyndromeAtypical vascular accidents of the newbornUrine TestingInfant urine toxicology tests are known to have high false-negative rates because only results for infants with recent exposure will be positive.Length of time after use that drug may still be detected in urine (adults):Cocaine: 4-7 daysHeroin or PCP: 2-4 daysMethadone/Buprenorphine: up to 10 daysMarijuana: 2-21 daysOxycodone (found in Percocet, OxyContin, etc): under 4 daysBuprenorphine and it’s metabolites can be tested for in urine and it reported separately, requires 1 ml of urineMeconium ScreeningDetects in-utero drug exposure over a much greater length of timeResults are much more reliable if test sample is obtained from initial passage of meconium.Oxycodone can be detected in the routine meconium toxicology screen as part of the opioid assay. Methadone is part of the routine opioid assay.Buprenorphine is not tested in meconium.Intrapartum drugs prescribed to control labor pain can be detected in meconiumDisposition Labor and DeliverySkin to skin is available immediately after delivery provided infant/mother are stablePer routine admission guidelines, SEN will be admitted to the Mother Infant Unit with mother provided there are no other comorbidities. If any of above maternal or newborn risk indicators are applicable, meconium should be collected and saved in a sterile container (kept refrigerated) for toxicological analysis. In addition, urine should be collected for toxicological analysis. Newborn Nursery ESC evaluation tool should be initiated 4 hours after birth and continue every 3 – 4 hours until discharge from hospital for infants with known / suspected substance of use/opioid exposure.ESC evaluation tool should be initiated 4 hours after birth and continue every 3 – 4 hours for those infants exposed to chronic prescribed opiates 6 weeks or longer during the pregnancy.ESC evaluation tool should be initiated 4 hours after birth and continue every 3 – 4 hours for those infants exposed to daily-prescribed opiates for 2 weeks or longer just prior to delivery.If signs/symptoms of withdrawal develop, then the Attending Pediatric Care Provider responsible for the infant should be notified.PRN Morphine given per policy on MIU, see pharmacologic management belowSpecial Care Nursery/Pediatric UnitIf the mother is an inpatient, then the SEN requiring greater than 2 doses of prn morphine within 24 hours for withdrawal should be transferred to the SCN from Newborn Nursery. Infant should be placed in private room to minimize stimulation. If the mother is being discharged and the SENwill remain in the hospital until discharge criteria met. Stable infants may be transferred to Pediatric Unit for NAS management at any time after mother’s discharge from MIU to allow/encourage rooming-in, skin-to-skin, and breastfeeding.ManagementSupport of the Family and InfantEncourage the mother and family to room-in with the infant as much as possibleEncourage breastfeeding in mothers meeting criteria and who choose to breastfeed (See Breastfeeding of the Newborn Policy)Parent(s)/caregivers are to be taught ESC Care tool and encourage their assessment of their infant while infant remains in mother’s room. Parent(s)/caregivers shall be taught:To assess their infant’s cuesTo interpret those cues for more or less interactionSynchronize their care and behavior with that of the infantTo organize care and handling so that infant is not over stimulatedTo utilize graduated interventions in quieting the fussy infantTo appreciate the infant’s unique competencies and ability to interact with his/her environmentContinuity of care (SW, case management) consultation for familyFamilies will be offered cuddler support services during admission. Staff will recommend cuddler if parents/caregiver are not available.Physical and Occupational Therapy consultation for all infantsEarly Intervention referral will be made as soon as possible, and included in daily care planNon-Pharmacologic TreatmentEvery SEN should receive the following care:Holding/ gentle rocking/swing/swaying head to toe directionDecreased stimulation (light and noise)/calm environment/slow movementsPositioning with hands to face and flexed extremities when swaddlingSkin-to-skin contact with parents (if possible)Feeding on demandPacifierPromote continuous sleep between feedsPharmacologic TreatmentMonitoring: Pulse oximetry monitoring must be in place when using any type of pharmacotherapy for management of Neonatal Abstinence Syndrome (NAS). Any other monitors per unit policy.ESC Evaluations:ESC Care Tool should be completed every 3 - 4 hours for the duration of inpatient stay.The decision to begin pharmacologic treatment should be based on data obtained from assessments performed with the infant, caretaker and nurse.Decision to initiate pharmacologic treatment:If infant is less than 24 hours old, try to avoid initiation of medication. Non-opioid withdrawal from co-exposures is likely to occur during this time.If infant is less than 24 hours old, maximize E (eat), S (sleep), C (console) measures and continue to educate family. Maximize non-pharmacologic treatment, including skin-to-skin, swaddling and minimizing light and noise exposure.If infant continues to have a “yes” to any ESC care tool item or “3s” for soothing support used to console infant and all nonpharmacological care has been optimized then consider pharmacologic treatmentChoosing Medications:For infants exposed to opioids (e.g. heroin, methadone, and oxycodone), begin pharmacotherapy with Neonatal Morphine Solution 0.4 mg/ml solution.For infants with multiple drug exposure, treat with neonatal morphine solution 0.4 mg/ml solution if exposed to opioids. In studies where opioids are used with other drugs (SSRIs, benzodiazepines, barbiturates), infants more frequently require two medications to control NAS symptoms.For infants who are NPO begin pharmacotherapy with IV Phenobarbital (same dose as PO). IV morphine has not been well-studied in NAS, is 3-6 times MORE potent than oral morphine, and has a more rapid onset of activity. These factors place infants at a greater risk for adverse effects, including respiratory depression and sedation. First Line Medication: NEONATAL MORPHINE ORAL SOLUTION (NMS) Neonatal Morphine Solution 0.4 mg/ml solution - Advantages Appropriate for treatment of opiate-exposed infantsShort half-life (4-12 hours) - therefore easy to titrateImproves GI symptoms Facilitates weight gain Decreases irritability Neonatal Morphine Solution 0.4 mg/ml solution - Disadvantages Requires frequent dosing Risk of medication errors because of the need for 5-fold dilution from full strength morphine solution. Cannot send baby home on Neonatal Morphine due to risk of abuse by adults.Neonatal Morphine Solution - Potential Side Effects Drowsiness Constipation Overdosing may cause narcosis manifested by decreased reflexes including poor Moro reflex, suck, grasp, and response to pain. More profound narcosis may be manifested by hypotonia, obtundation, coma, respiratory rate <20 per minute, irregular shallow respiration, apnea, hypotension, bradycardia, and hypothermia.Dosing guidelines for NMS: PRN dosing If infant has not yet been transferred to pediatric unit, infant should be placed on saturation monitor either in SCN Parenting room or in NBN. Infant to remain in NBN census (if in SCN Parenting room). Encourage nonpharmacological care of infant by primary caretaker or cuddler.Administer neonatal morphine solution 0.05 mg/kg/dose based on birthweight unless current weight is higher than birthweight.Infant will be on pulse oximetry monitoring for 2 hours after medication administered. (Onset of immediate release is approximately 30 minutes.)If there are no prolonged desaturations (>30seconds and <89%) then infant can return to routine care in Mother and Infant Unit and continue with nonpharmacological care and ESC care tool.If infant continues to have a “Yes” to any ESC care tool item or “3s” for Soothing Support used to console infant consider using a second dose of NMS as described above.Continue to reassess and maximize nonpharmacological intervention. If more than 2 PRN doses are needed within a 24 hour period infant will be transferred to SCN or Pediatrics for further management.Infant may continue to receive PRN dosing after transfer. Neonatal morphine should be ordered as 0.05 mg/kg/dose PO q3 hours PRN based on birthweight unless current weight is higher than birthweight. If more than 4 PRN doses are needed in a 24 hours period, begin scheduled morphine dosing as described below.Dosing Guidelines for NMS: Scheduled Dosing Initiating scheduled dosing:To begin scheduled dosing, neonatal morphine should be ordered as 0.05 mg/kg/dose PO q3 hours based on birthweight unless current weight is higher than birthweight.If infant continues to have a “Yes” to any ESC care tool item or “3s” for Soothing Support used to console infant consider increasing dose by 0.05 mg/dose (NOT mg/kg/dose).Dose may be increased every 2-3 doses until infant no longer has a “Yes” to any ESC care tool item or “3s” for Soothing Support used to console infant. Maximum dose is 1 mg/kg/day.If the maximum dose is reached and symptoms persist, a second medication should be added. May consider adding a second medication sooner (when at neonatal morphine solution ~0.8 mg/kg/day) if the infant also exposed to SSRIs, benzodiazepines or barbiturates. See below.Stabilization: Hold therapeutic dose for 24-48 hours once infant ESC Care Tool items are primarily “No” and all non-pharmacologic measures are optimized.Weaning: If using both neonatal morphine solution 0.4 mg/ml and Phenobarbital or Clonidine, wean neonatal morphine solution first. Neonatal morphine solution must be weaned as an inpatient.Begin weaning once infant ESC Care Tool items are primarily “No”, and wean by 10% of maximum dose. Do not readjust weaning increment for changes in weight.Wean 1-2 times per day if infant has primarily “No” to any ESC care tool and “1” or “2” for Soothing Support.If withdrawal symptoms increase following a wean in the dose, increase back to the last effective dose, stabilize for 24-48 hours, and resume weaning with original 10% decrement.Discontinuing neonatal morphine:Discontinue neonatal morphine solution when the infant has reached 0.04 – 0.06 mg per dose.Monitor the infant in the hospital with continued ESC Care Tool assessments for 36 – 48 hours after discontinuation of the medication.Second Line Medication: CLONIDINE Clonidine - Advantages Controls CNS irritability and autonomic symptoms Does not expose infant to the potential long-term adverse neurodevelopmental effects of phenobarbital Clonidine - Disadvantages Frequent dosing Cannot send infant home on Clonidine Clonidine – Potential Side Effects Hypotension Bradycardia Rebound hypertension Clonidine – Administering Formulation: 5 mcg/mL oral solutionDo not prescribe for outpatient useConsider using Clonidine as a second line agent for infants exposed to opioids that are on high doses of neonatal morphine solution with persistent symptoms, particularly if there is a history of maternal poly-substance use/abuse.Infants <7 days old: Start with 4-6 mcg/kg/day, divided q6hrs (1-1.5 mcg/kg/dose) or q4hrs (0.75-1 mcg/kg/dose).Infants >7 days old: Due to increased renal clearance of clonidine > 7days, consider starting at 6-8 mcg/kg/day if > 7days or increasing dose at 1 week if already on medication.Escalating Dose: If infant continues to have a “Yes” to any ESC care tool item or “3s” for Soothing Support used to console infant, may increase to maximum of 12 mcg/kg/day. May change dosing to q4hrs.Clonidine – Monitoring: Monitor blood pressure every 4 hours x 24 hours after initiation of treatment.Monitor blood pressure 1-2 hours after dose 1-2 times/day.Clonidine – Weaning Wean infant from neonatal morphine prior to starting clonidine wean. Begin clonidine wean 12-24 hours after stopping neonatal morphine.Clonidine must be weaned as an inpatient.While weaning, monitor blood pressure prior to new dose (if dosing q6hrs) or >6 hours after new dose 1-2 times/dayWean clonidine by 25% per day every 24 if infant has primarily “No” to any ESC care tool and “1” or “2” for Soothing Support.May keep dose the same and lengthen dosing interval (q6 to q8 to q12 to q24) or decrease dose by 25% and keep interval q6hrs.If infant symptoms increase during weaning, increase to previous effective dose (0.25 mcg/kg higher) and hold at this dose for 24 hours prior to re-starting wean.Clonidine – Discontinuing Discontinue when dose is ???Monitor BP every 4 hours for 48 hours after stopping clonidine.Consider a 1 mcg/kg “rescue” dose of clonidine for persistent systolic BP > 95th% at rest, and then monitor for additional 36-48 hrs prior to discharge.Clonidine must be weaned as an inpatient.Third Line Medication: PHENOBARBITAL Phenobarbital - Advantages Is not an opioid Controls CNS irritability and insomnia Less frequent dosing Can send baby home on Phenobarbital Phenobarbital - Disadvantages Long half-life (40 hours) - therefore, can be difficult to titrate Need for blood draws to monitor serum levels Does not control diarrhea or other GI symptoms Large doses may cause CNS depression, depress suck reflex and negatively affect feeding Phenobarbital – Potential Side Effects DrowsinessHypotensionSkin rashGrowing concern for adverse long-term developmental outcomes and CNS injury based primarily on animal studies (Forcelli, et al 2010).Phenobarbital - Administering LoadingLoad with 20 mg/kg x 1 dose or 10 mg/kg q6-12 hrs. x 2 doses (should result in a plasma level of about 20-30 mg/ml).If infant continues to have a “Yes” to any ESC care tool item or “3s” for Soothing Support used to console infant consider-loading with 10 mg/kg/dose every 8-12 hours as needed x 2 more doses, until the cumulative total of all loading doses reaches a maximum of 40 mg/kg.Loading doses may be given POMaintenanceBegin maintenance dosing based on sum of loading doses 12-24 hours after last loading dose.Cumulative Sum of Loading DosesMaintenance Dose20 mg/kg5 mg/kg/day30 mg/kg6.5 mg/kg/day40 mg/kg8 mg/kg/dayGive maintenance dose every 24 hours in the evening. Some infants may do better with daily dose divided q12hrsSteadyMonitoringSteady state will be reached at around 7-10 days (5 half-lives).The ideal serum level to control NAS is <30 mg/ml.Draw trough level after 1 week of treatment unless a cumulative total of 30 mg/kg of loading doses has been given, in which case draw a serum level prior to giving any further medication. Consider level prior to discharge to aid with post-discharge weaningAdditional serum levels may be drawn as clinically indicated.WeaningWean neonatal morphine prior to phenobarbital wean.. Begin phenobarbital wean 12-24 hours after stopping neonatal morphine.Phenobarbital may be weaned by the primary care physician as an outpatient.The dose may be decreased by 25% once or twice per week over a period of 2-4 weeks. Discharge CriteriaInfants receiving PRN morphine will be evaluated as an inpatient for 24- 36 hours after their last dose of morphine. ESC care tool assessments should be continued during this time.Infants weaned off scheduled oral morphine will be evaluated as an inpatient for 36-48 hours after their last dose of morphine. ESC care tool assessments should be continued during this time.All newborns evaluated for NAS, including those without necessity of pharmacologic treatment, should have a follow-up appointment with heir PCP scheduled within 24-48 hours of discharge.Newborns should not have received a “Yes” for sleeping or consoling in the ESC care tool in the 24 hours prior to discharge.Newborns should not have received more than one “3” for Soothing Support in the 24 hours prior to discharge.Parent support:Infant should be able to remain in crib or bassinet for at least one 2-hours period without needing intervention prior to discharge.Parent/care giver should be able to demonstrate ability to use 5 S’s of soothingParents should have attended newborn care class. Foster care givers will be offered option to attend newborn care class prior to discharge.Safe sleep environment at home will be confirmed with parent/ care giver.Period of Purple Crying information will be given to parent/ care giver.Parents/ care givers will have watched appropriate newborn education videos on the Get Well Network.Feeding:Newborns will have met age appropriate feeding goals.Parents/ care givers will demonstrate ability to effectively feed newbornNewborn weight loss will have stabilized or infant will be gaining weight.Continuity of CareSocial work evaluation and Plan of Safe Care will have been completed, including identifying supports for care giver at home.DCF case manager will be involved in discharge plan and have agreed to Plan of Safe Care.Family will agree to accept home services recommended by care team including but not limited to VNA, Early Intervention, and Welcome Families. In accordance with Federal Law (Individuals with Disabilities and Education Act 2004, section – 637 (a)-6), a developmental evaluation should be made prior to discharge for any infant exposed to medically prescribed opiates or illicit drug use in utero. A referral to the Early Intervention Program (EIP) will satisfy this requirement. REFERENCE(S): Grossman, M; Lipshaw, M; Osborn,R; Berkwitt, A.: A novel approach to assessing infants with Neonatal Abstinence Syndrome. Hospital Pediatrics, Vol 8 Issue 1 January, 2018 p. 1-6Wachman EM, Grossman M, Schiff DM, Philipp BL, Minear S, Hutton E, Saia K, Nikita F, Khattab A, Nolin A, Alvarez C, Barry K, Combs G, Stickney D, Driscoll J, Humphreys R, Burke J, Farrell C, Shrestha H, Whalen BL. Quality improvement initiative to improve inpatient outcomes for Neonatal Abstinence Syndrome. J Perinatol. 2018 Aug;38(8):1114-1122.Grossman MR, Berkwitt AK, Osborn RR, Xu Y, Esserman DA, Shapiro ED, Bizzarro MJ. An Initiative to Improve the Quality of Care of Infants with Neonatal Abstinence Syndrome. Pediatrics. 2017 Jun;139(6).American Academy of Pediatrics Policy Statement. “Neonatal Drug Withdrawal” Pediatrics. 129(2): February 2012; pp 540 – 555Health and Human Services Blueprint on Breastfeeding: , Thomas W. Medications and Mother’s Milk, 13th edition, 2017ASSOCIATED DOCUMENTS via MIU: Document A. A guide to helping your newborn thriveDocument B. NAS/ Caring for your Baby BrochureDocument C. ESC Care Tool Algorithm POLICY TRACKING RECORDSupersedes: Urine: Obtaining Neonatal Urine and/or Meconium Specimens for Drug Screens (2/06) AND Breastfeeding: When a mother is on Methadone Treatment (3/06) ................
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