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Feasibility and Safety of Therapeutic Hypothermia and Short-Term Outcome in Neonates with Hypoxic Ischemic Encephalopathy – Experience from NICU of a Rural Secondary Care Hospital.

DR.MADAMANCHI BHASKAR NNF FELLOW RDT HOSPITAL BATHALAPALLI, ANANTAPUR, AP. GUIDE: DR. J DASARATHA RAMAIAH HOD, DEPT OF PAEDIATRICS, RDT HOSPITAL

INTRODUCTION

• Neonatal encephalopathy following perinatal asphyxia in neonates is still

a common and serious condition1.

• Infants with moderate-to-severe neonatal encephalopathy carry a high

risk of adverse outcome, such as mortality, cerebral palsy, neuro developmental impairment2.

• Various Published studies indicate that Therapeutic Hypothermia (TH) for

Hypoxic Ischemic Encephalopathy increase survival without neurological sequelae.

• However, it is not the standard of care in many neonatal intensive care

units (NICUs) in India.

AIM &OBJECTIVE

• Aim: To assess the feasibility, safety, and effectiveness of TH in a rural

secondary care Hospital.

• Objective: To determine the characteristics of the newborns kept on TH,

birth conditions, features of body temperature control, clinical complications, adverse events, and outcome.

MATERIALS & METHODS

• Place of the study: NICU of Rural Development Trust

Hospital, Bathalapalli, Anantapur, Andhra Pradesh.

• Study Design: Retrospective Observational Study
• Study period: July1, 2018 to July 31, 2019 (13 months)
• Inclusion criteria: Newborns with moderate to severe birth asphyxia

according to modified Sarnat staging 3 who had been treated with TH.

METHODOLOGY

• Target temperature (33.50 C) was achieved by using phase changing material-

based device – (Mira Cradle- Neonate Cooler) which was developed by Pluss Advanced Technologies Pvt.Ltd in collaboration with CMC Vellore.

• The newborns were monitored and managed as per predesigned unit

protocol.

• The data collection (from the hospital records) include:
• perinatal characteristics of newborns
• blood gas within first hour of life
• severity of encephalopathy, time to start TH
• time to reach target temperature (33.50C)
• adverse events during hospital stay
• outcome
• Fidgety Movements were assessed at 9 to 15 weeks of age

STASTICAL ANALYSIS

• We Performed descriptive analysis on the data.
• Qualitative variables are expressed as absolute and relative frequencies.
• Numerical variables are expressed as mean, median, minimum and

maximum values.

RESULTS

Perinatal Characteristics

Categorical Variables Absolute Frequency Percentage Sex - Male 34 61.8 % Female 21 38.2 % MOD- NVD 23 41.8 % Assisted VD 12 21.8 % LSCS 20 36.3 % Place of Delivery: In Hospital 44 80 % Extramural 11 20 % Encephalopathy at admission- Moderate 42 76.3 % Severe 13 23.6 %

RESULTS

Numerical Variables

• APGAR score at 5 minutes: Median Minimum Maximum

5 3 7

• 1 st Hour Blood Gas : Mean Minimum Maximum

pH 7.15 6.87 7.31 BE - 12.64 - 25.4 -1.2

FEASIBILITY MEASURE

• For all babies, TH was initiated within 6 hours of life.
• Mean age at initiation of TH is 2 hours 40 minutes.
• Mean time of achievement of target temperature is 1 hour 40 minutes.
• Cooling was discontinued before 72 hours 4 (7.2 %) babies due to severe

refractory shock and coagulopathy (3) and moribund encephalopathy (1).

• The mean duration of rewarming after TH was 13 hours 20 minutes with

rate of rewarming 0.220C/ hr.

SAFETY MEASURE(ADVERSE EVENTS)

5 10 15 20 25 30 35 40

OUTCOME

Discharged (43) LAMA(6) Died(6)

DISCHARGED (78%) DIED(10.9%) LAMA(10.9%)

All discharged babies were on breastfeeds and 6(13.9%) babies were on anticonvulsants at the time of discharge

FIDGETY MOVEMENTS

(9-15 WEEKS OF AGE)

NormalFidgety Movements Abnormal Fidgety movements

Normal Fidgety Movements 28 ( 80%) Abnormal Fidgety Movements 7 (20%)

DISCUSSION

• In this study we observed that TH can be practiced in Rural secondary

hospital NICUs with well defined protocol.

• Time taken to reach target temperature(33.5 0C) in study is 100 minutes

which is lower than a Published multi centric Indian Study4( 120 min) but more than NICHD Trail5 (90 min) which used servo-controlled equipment.

• The temperature fluctuations above upper limit(33.8oC )were similar

(6.9% vs 5.7) , but the fluctuations below lower limit(33.20C) were significantly lower (2% vs 5.1) when compared to study by Thomas N4 et al.

DISCUSSION

• Rewarming rate is slow (0.220 C/hr) when compared to the multi centric

study4 (0.280 C/hr).

• The adverse events in our study were comparable to Thomas N 4et al

study.

LIMITATIONS

• There is no control group
• Long term follow up of the babies is needed.

CONCLUSION

• TH is a safe and effective intervention and can be practiced in secondary care

hospital NICUs

• Prerequisites for practice of TH as a standard of care in secondary care

hospital NICUS are:

• Neonate whole body cooler
• Established Protocol
• Bedside 2D Echo
• Training of Staff
• Expertise to secure and aseptically maintain Umbilical venous catheter

REFERENCES

• 1. Hakobyan M, Dijikman K,Laroche S,Naulaers G, Rijken M, Steiner K et al. Outcome of

Infants with Therapeutic Hypothermia after Perinatal asphyxia and Early onset sepsis.Neonatology.2018;115(2):127-133.

• 2. Pin TW, Eldridge B, Galea MP. A review of developmental outcomes of Term infants with

post- asphyxia neonatal encephalopathy. European Journal of Pediatric Neurology.2009; 13(3):224-34.

• 3. Sarnat HB, Sarnat MS.Neonatal encephalopathy following fetal distress. A clinical and

Electroencephalographic study. Arch Neurol.1976;83:696-705.

• 4. Thomas N, Abiramalatha T, Bhat V, Varanattu M, Rao S, Wazir S et al. Phase Changing

Material for Therapeutic Hypothermia in Neonates with Hypoxic ischemic Encephalopathy- A Multi-centric study. Indian Paediatrics.2017; 55(3)201-205.

• 5. Shankaran S, Natarajan G,Chalak L,Pappas A,Mc Donald S,Laptook A. Hypothermia for

Neonatal Hypoxic ischemic Encephalopathy: NICHD Neonatal Research Network Contribution to the field. Seminars in Perinatology.2016;40(6):385-390.

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