7/11/2018. Oral Dextrose Gel Treatment for Newborns with Hypoglycemia Reduces NICU Admissions DISCLOSURE. Objectives

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1 Gaps in Knowledge, Competence, Performance, or Patient Outcomes DISCLOSURE The content of this presentation does not relate to any product of a commercial entity; therefore, I have no relationships to report. Professional Practice Gap(s) Predictable problems with particular conditions Need for anticipation Prepared to intervene Desired Results Be aware of particular potential complications Anticipation Preparations for additional intervention, as needed Oral Dextrose Gel Treatment for Newborns with Hypoglycemia Reduces NICU Admissions American Academy of Pediatrics District VIII Section on Neonatal Perinatal Medicine 42 nd Annual Conference Stephen Minton, MD, Medical Director, Chief of Neonatology; Kristie Fitzgerald, R. Ph.; Jodi Weidman, RN; Cynthia Spencer, RN; and, Larry Eggert, MD Utah Valley Hospital, Provo, Utah June 24, 2018 Midway, Utah Objectives Participants should be able to: 1. Understand that infants vary in their ability to tolerate low blood sugar and no single value for hypoglycemia can be defined 2. Understand the use of buccal 40% dextrose gel in the treatment of neonatal hypoglycemia 3. Appreciate the significant reduction in NICU admissions (cost)with our hypoglycemia protocol approach Neonatal hypoglycemia affects as many as 5 15% of babies It is responsible for most transfers from Mother/Baby to the NICU It is extremely expensive to treat It causes significant frustration in new parents Standard Practices to Treat Hypoglycemia Supplemental feeds: expressed breast milk, donor human milk, or formula IV glucose with admission to NICU Increased cost Less invasive Separates mom and baby Interrupts breast feeding and bonding Decreases time for skin to skin This Photo by Unknown Author is licensed under CC BY SA 1

2 Definition of Neonatal Hypoglycemia 2008 expert panel at National Institute of Child Health and Human Development. No evidence threshold levels had been established relating levels of glucose to pathologic neonatal hypoglycemia in infants Committee on Fetus and Newborn & Adamkin. Lack of clinical evidence defining pathologic glucose levels during the first hours of life During Pregnancy Continuous flow of nutrients Birth Disruption of continuous flow of nutrients Immediate endocrine and metabolic changes Neonatal Metabolic Adaptation Hormonal Insulin Glycogen Catecholamine Cortisol Metabolic Glycogenolysis Glyconeogenesis Lipolysis/free fatty acids Ketogenesis Neonatal Metabolic Adaptation Neonatal Metabolic Adaptation Blood glucose levels fall in the hours after birth in all infants, particularly those who are breastfed Physiologic fall These infants have high ketone body levels when blood glucose concentrations are low, and it is likely that these alternative fuels protect them from neurologic injury. Formula feeding is associated with lower ketone body levels compared with levels in breastfed infants. Breast milk is preferred instead of formula. There is a continuum between the normal physiologic fall in blood glucose after birth accompanied by protective metabolic responses In some babies, there is a delay or failure or the normal metabolic adaptation resulting in lower blood sugars Hypoglycemia at this time should actually be diagnosed as impaired metabolic adaptation. Impaired or Delayed Metabolic Adaptation At Risk Groups Hyperinsulinism (poor control of maternal diabetes in pregnancy) IUGR Preterm infants Other pathologic conditions, examples: Perinatal stress Infection Inborn errors of metabolism If untreated, the low blood glucose levels in the absence of alternative fuels to glucose can cause clinical signs and, in the extreme case, brain injury. 11 Clinical Significance of Impaired or Delayed Metabolic Adaptation When neonatal hypoglycemia results in clinical signs or brain injury, the temporal evolution is: Biochemical hypoglycemia with adequate metabolic adaptation Low blood glucose levels are found, but the infant does not have clinical signs because he or she is still able to draw on alternative fuel stores Impaired metabolic adaptation If untreated, the infant exhausts alternative fuel stores and develops subtle clinical signs that are not specific to hypoglycemia (e.g., irritability, lethargy, poor feeding), but hypoglycemia is not damaging at this stage. 2

3 Metabolic adaptation has failed If untreated, the infant develops obvious and severe clinical signs (most usually hypotonia, reduced level of consciousness or seizures, coma) but may escape damage if treated promptly. Hypoglycemia becomes damaging If not treated sufficiently soon after the onset of these severe clinical signs In severe cases, cardiorespiratory arrest Profound and prolonged hypoglycemia has been associated with both transient and permanent structural changes in the brain (especially if seizures occur) Grey matter, with parieto occipital area most affected Clinical Significance of Impaired or Delayed Metabolic Adaptation No study has yet satisfactorily addressed the duration of absent or reduced availability of metabolic fuels that is harmful to the human neonate. Animal studies indicate that hours (rather than minutes) of hypoglycemia are required to cause injury AND that injury is likely to occur if abnormal clinical signs are absent. Time period for injury is highly variable. Severe hyperinsulinism, metabolic adaptation is completely suppressed, newborn extremely vulnerable. Moderate preterm infants who do not get sufficient milk intake, have a more gradual process as the infant s reduced fat stores become exhausted Evidence based Clinical Diagnosis If there are neurologic signs in association with blood glucose levels <45.0 mg/dl, there should be an urgent investigation to identify an underlying cause and institution of treatment. For infants who have no clinical signs but are at risk of impaired metabolic adaptation intervention to raise the infant s blood glucose level should be instituted if two consecutive blood glucose levels are <36 mg/dl, measured by using an accurate device, or a single blood glucose level is <18 mg/dl. NOTE: Intermountain has chosen to use an actionable glucose of <40 instead of <45 or <36 Cornblath, M et al. Controversies regarding definition of neonatal hypoglycemia: suggested thresholds. Pediatrics Postnatal Glucose Homeostasis in Late Preterm and Term Infants; Committee on Fetus and Newborn; Pediatrics 2011;127;575 Dextrose gel for neonatal hypoglycemia (the Sugar Babies Study): a randomized, double blind, placebo controlled trial Deborah L Harris, Phillip J Weston, Matthew Signal, J Geoffrey Chase, Jane E Harding Methods: Randomized, double blind, placebo controlled at tertiary center in New Zealand in 2010 Neonates weeks gestation < 42 hours old, at risk of hypoglycemia were randomly assigned to 40% dextrose gel (200mg/kg) or placebo gel 514 enrolled babies, 242 became hypoglycemic and were randomized, 237 eligible for analysis: 118 in dextrose gel group 119 in placebo group Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study); Harris et al.; Lancet 2013;382: Buccal Dextrose Gel Application The researcher or midwife dried the baby s mouth with gauze, massaged 200 mg/kg (0.5 ml/kg) gel into the buccal mucosa, and the baby was encouraged to feed. If feeding was poor, the baby was given expressed breast milk or formula by syringe, according to maternal wishes. The blood glucose concentration was measured 30 min after gel administration and, if the baby remained hypoglycaemic or hypoglycaemia recurred later, treatment was repeated with another syringe from the allocated pack. Up to six doses of gel could be given over 48 h. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study); Harris et al.; Lancet 2013;382:

4 Findings Dextrose gel reduced frequency of hypoglycemia Neonates receiving dextrose gel were: Less likely to be admitted to NICU for hypoglycemia Less likely to receive IV dextrose Less likely to have episodes of recurrent hypoglycemia Less likely to need expressed breast milk or supplementation with formula No serious adverse effects noted Well tolerated by neonates Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study); Harris et al.; Lancet 2013;382: Methods Following review of the neonatal hypoglycemia literature, Intermountain Healthcare in 2015 initiated a pilot hypoglycemia algorithm for newborns greater than 34 weeks at Utah Valley Hospital. There were asymptomatic and symptomatic guidelines Specific modifications included: Feeding all term and late preterm infants as soon as ready, preferably within one hour of birth. (Feedings should be breast milk (colostrum) or pasteurized human milk (PHM). Delaying the time of initial glucose testing for asymptomatic, at risk babies to 2 to 3 hours of age before the second feeding (after the physiologic fall and recovery in blood glucose level following birth). Lowering the actionable glucose threshold to less than 40 mg/dl. If glucose level is less than 40 mg/dl, administering buccal dextrose gel based on weight, feeding with follow-up glucose level in 30 minutes. The protocol permitted multiple dextrose gel uses. If, however, a baby needed 3 gels in a row or 6 gels in 24 hours, they were transferred to the NICU for IV therapy. Pre-feeding monitoring should be continued (approximately every 4 hours) until the infant has had at least two satisfactory measurements Monitoring should be recommended if the infant s clinical condition worsens or energy intake decreases. (Feeding is very important ) If monitoring is performed by using reagent strips, low levels must be confirmed promptly by accurate measurement consecutive glucose levels <40 or SYMPTOMATIC > follow arrow to Symptomatic (right) side of algorithm

5 HYPOGLYCEMIA RESULTS March 11, 2015 March 12, 2016 Prevention and Management of Neonatal Hypoglycemia If an infant requires intravenous glucose, usually 10% dextrose at 3 ml/kg/h (5 mg glucose/kg/min) is sufficient to prevent or reverse hypoglycemia. If boluses are required (e.g., if there are neurologic signs of hypoglycemia), they should be of 10% dextrose (3 5 ml/kg), given slowly, and always followed by an infusion. At risk infants should generally not be discharged at less than age 48 hours and only when experienced staff are satisfied that feeding is effective Total Babies 1250 Gel Gel Gels Gels Gels Gels Gels LGA 199 Gel: 43 NICU Admits: 1 Would have received IV Bolus: IDM 145 Gel: 45 NICU Admits: 0 Would have received IV Bolus: IDM + Other Risk 46 Gel: 17 NICU Admits: 3 Would have received IV Bolus: SGA 382 Gel: 81 NICU Admits: 3 Would have received IV Bolus: Premature <37 wks 143 Gel: 51 NICU Admits: 3 Would have received IV Bolus: SGA + Premature 44 Gel: 17 NICU Admits: 0 Would have received IV Bolus: Jittery 200 Gel: 53 NICU Admits: 5 Would have received IV Bolus: Jittery + Other Risk 41 Gel: 25 NICU Admits: 4 Would have received IV Bolus: Other 50 Gel: 24 NICU Admits: 2 Would have received IV Bolus: Total Gel Doses: Percent of Total Babies Receiving gel 356 Not included were 3 babies requiring gel but did not receive any gel Likely NICU transfers 224 Based on previous algorithm and normal hypoglycemia value 45 but remained in WBN NICU Transfers 21 3 transfers: received 3 rd gel dose in NICU; no IVP glucose 2 transfers: transferred for IVP glucose before gel given in WBN given. (BG very low) ** report adjusted for first draft 2 transfers: required 3 rd gel dose; no IV glucose given and 1 transfer: transferred because gel x6 / 24 hours of algorithm that called for gel transferred back to WBN 1 transfer: polycythemia (persistent hypoglycemia with Hgb given to symptomatic babies with 7 transfers: transferred because gel x3 consecutively 23) glucose Those gel doses 4 transfers: symptomatic not responsive to gel (required 1 transfer: received 4 gels, weak/no suck, and required gavage were deleted. IV) feedings every feeding Results Study period: March 11, 2015 March 12, 2016 Number of births 4,411 Number of patients 34 weeks who entered protocol 1,250 (28.3%) Number of patients asymptomatic at risk 1,009/1,250 (80.7%) Number of patients symptomatic 241/1,250 (19.3%) Results Gel Use Number of patients who received gel 356/1250 (28.5%) Number asymptomatic patients receiving gel Number symptomatic patients* receiving gel LGA/IDM/IDM plus other receiving gel SGA receiving gel Premature < 34 0/7 366/7 weeks Premature plus SGA 254/959 (26.5%) 10 / 254 (3.9%) 102/291 (35%) 11 / 102 (10.8%) 105/390 (26.9%) 4/105 (3.8%) 81/382 (21.2%) 3/81 (3.7%) 51/143 (35.7%) 3/51 (5.9%) 17/44 (38.6%) 0/17 (0%) * Jittery 53/145 (36.5%) Results Number of Gel Doses One dose 200 / 356 (56.1%) Two doses 84 / 356 (23.6%) Three doses 45 / 356 (12.6%) Four doses 16 / 356 (4.5%) Five doses 7 / 356 (2.0%) Six doses 4 / 356 (1.1%) 79.7% treated with two doses 92.3% treated with three doses Results NICU Admissions Failed Hypoglycemia Algorithym Number IVP Continuous IV Gel x 3 consecutive Gel x 3 consecutive Gel x 3 consecutive Before any gel in WBN (BG very low) Symptomatic and low BS not responsive to gel x Persistent hypoglycemia and polycythemia Gel x 4 (gavage feeding, weak, no suck) Gel x Totals

6 Conclusion NICU admissions for neonatal hypoglycemia reduced 224 cases in one year (91%). Most patients enrolled in asymptomatic at risk protocol (80.7%). 26.5% received gel. Only 3.2% admitted to NICU. Most patients received one gel dose (56.1%), two gel doses in 23.6%. Gel was used in 26.9% of LGA/IDMs, 21.2% SGA, and 35.7% of prematures. 21 patients failed protocol and transferred to the NICU 4 did not respond to gel in WBN 5 corrected on admission to the NICU did not receive IVP 2 did not receive continuous IV glucose in NICU Gel given to 35% symptomatic newborns. Only 3.8% admitted to NICU. Conclusion Cost reduction approximately $800,000/year. Nursing staff, physicians, and parents loved the protocol. Babies tolerated gel and administration well. Gel was easy to administer. Inappropriate feeding is a major cause of failure. A champion for the protocol. Gel costs $.08 per 0.8g/2 ml. Gel is stable in room air. 6