Research Proposal

Evaluation of Regional Cerebral, Abdominal and Renal

Oxygenation in Unintended Hypothermic Infants by Using
NIRS (Near Infrared Spectroscopy).
Introduction

Hypothermia therapy in asphyxiated infant seems good for brain. Because

hypothermia has been used as a neuroprotective. From several studies mentioned that
cooling decreases brain energy used, thereby reducing neuronal cell loss and
preserving brain structures therapy. (Dixon and Bahrami, 2016) However, hypothermia
may have different effects to infant might suffer from circulatory failure, hypoglycemia
and even organ damaged. Hypothermia may divert calories to produce heat, growth
impairment and increases the metabolic rate and O2 consumption. Persistent
hypothermia can result in metabolic acidosis and increases the risk of late-onset sepsis
and mortality. (Gibson et al, 2015) Compared with the adult, neonatal has a limited
ability to increase oxygen consumption, to produce heat by shivering, or to dissipate
excess heat through sweating.
In Indonesia, referral system is not yet well established. Baby whose pre-
transport stabilization is not in accordance with STABLE rules (Sugar, Temperature,
Airway, Blood, Laboratory, Emotional). The babies tend to be hypothermia (unintended
hypothermia).
In this study we will observe newborn less than 3 days of age who is born and
admitted to Soetomo General Hospital in Surabaya with unintended hypothermia or
temperature below 36°C. We will measure regional oxygenation in cerebral (RcSO2),
kidney (RkSO2), and abdominal (RaSO2) by using NIRS, continuously until warming
phase temperature > 37°C degrees. Then we can calculate FTOE that compares with
spo2 in cold phase and warm phase. From this study, we want to know is there any
hypoxia insult in unintended hypothermia baby as an early marker for organ disfunction.

Expected Results of Research Project

We expect that publication media our result of research project is articles. Then
we hope that our experiment can be useful, usable and able to give enough information
about the effect of unintended hypothermia in regional tissue oxygenation.
Time of publication, we expect that can publish this research is 6 months after
finishing the research project.
 Concept Theory

- Stabilization Hypothermia
- Transportation (<36C)
- Cold
environment

Skin
Thermoreceptor
s

Preoptic
hypothalamus

Periferal Blood flow Adrenal Bradicardia Cerebral Renal blood flow 

Vasoconstriction digestive gland and Hypotension metabolic
system  Thyroid CO demand
stimulates and CO2 RkSO2
production 
RaSO2
Shivering
FTOE 
RcSO2 
FTOE 
Metabolism
FTOE 

Rewarming > 37C

RcSO2 
RaSO2
RkSO2

FTOE 
Methodology of Research Project

This cross-sectional study or observational clinical study involve 25 unintended

hypothermia newborns who is born and admitted to Dr. Soetomo General Hospital.
Inclusion criteria: the baby who temperature below 36°C are eligible to be placed the
INVOS TM OxyalertTM NIRSensors for neonates in 3 region head (placed on the
frontoparietal side of the infant’s head) RcSO2 ,abdominal RaSO2 , and on the lateral
posterior flank RkSO2, which represent cerebral, intestine, and kidney. Then the INVOS
TM Oxymeter will generate continuous noninvasive readings of regional blood oxygen
levels. Monitoring will be done until warming phase temperature > 37°C degrees. We
can compare cold phase (define) with warm phase (paired data) and correct admission.
Then analyze the different of RcSO2 (Regional Cerebral Oxygen Saturation),
RaSO2 (Regional Abdominal Oxygen Saturation), RkSO2, FTOE (Fractional Tissue
Oxygen Extraction) in each their regional. We calculated FTOE for each location as:
FTOE = (spO 2 – rSO 2 )/spO 2.
We will prospectively collect clinical collect clinical characteristics on the day of
clinical including heart rate, blood pressure, urine output, spO 2 , pCO 2, and
hemoglobin levels. We also collected GA, birth weight, Apgar score, postnatal age,
weight, ventilator mode and settings, and inotrope administration from the patients
medical charts.

Research Team

Researcher : Mahendra Tri Arif Sampurna, MD

Researcher assistant : Dwi Lestari Avianti MD, Sufiandika Nuryandari MD
Experts : Agus Harianto MD, Risa Etika MD, Martono MD,
Dina Angelika MD, Kartika MD
Local Research Nurses : Eli
A Pharmacist : Sukma R. Kharisma
Neonatologist : Agus Harianto MD, Risa Etika MD, Martono MD,
Dina Angelika MD, Kartika MD
Nurse to assistant researchers : Eri Setya, Siti Wahyuni, Chairumaani, Hari Setyorini,
Winati
Administrator : Kinanti Ayu Ratnasari, S.KM

List of Collaboration

Name Affiliation Position /Job Education Major role in

Title the project
Elisabeth UMCG Group Neonatology MD, PhD Supervisor
M.W.Kovi.MD.PhD staff in Beatrix
Children
Hospital
Prof.Arend F. UMCG Group Head of MD, PhD Supervisor
Bos.MD.PhD Neonatology
Department in
UMCG
Research Project Schedule

This research period will take 1 (one) year from April 2018 through March 2019, but it can be extended by another one year max.
if required with specific reason for fulfillment of the project.

No. Research Project Activities Apr May Jun Jul Agt Sept Okt Nov Dec Jan Feb Mar
1 First research coordination meeting
2 Review further literature
3 Complete Research Project Proposal
4 Revise proposal
5 Development of research tools
6 Validation of equipment
7 Data collection with patients of infant
8 Data entry and analysis
9 Data treatment and interpretation of result
10 Discussion and conclusion of the project
11 Editing paper of the project
12 Finish first draft of paper
13 Preparation and submission final report
14 Preparations of technical document and publications
15 Dissemination of study at Pediatric Academic Societies
(PAS) Meeting 2019
List of Budget

No. Category N Information Amount

(Rp) (Rp)
1 NIRS devices supported by PT 1 0 0
Binabakti Mitragemilang
2 NIRS probe supported by PT 8 sets 0 0
Binabakti Mitragemilang
3 Nurse to assistant researchers 5 1.500.000 7.500.000
4 Submit abstract 1 2.500.000
5 Administrator 12 1.500.000 18.500.000
months
6 Internet, email, and telephone fee 12 250.000 3.000.000
months
7 Stationery supplies 12 100.000 1.200.000
(A4 paper, pens, clips, printer’s ink, months
etc)
8 Fee statistician 2.500.000
Total Amount 34.700.000

Summary

Hypothermia in newborn has effects for circulatory failure, hypoglycemia and

even organ damaged. Persistent hypothermia can result in metabolic acidosis and
increases the risk of late-onset sepsis and mortality, but hypothermia can be as a
neuroprotective for babies. In Indonesia, referral system is not yet well established and
not accordance with STABLE rules. The babies tend to be hypothermia (unintended
hypothermia). In this study we will observe newborn less than 3 days of age who is born
and admitted to Soetomo General Hospital in Surabaya with inclusion criteria: the baby
who temperature below 36°C are eligible to be placed the INVOS TM OxyalertTM
NIRSensors for neonates in 3 region head (placed on the frontoparietal side of the
infant’s head) RcSO2 ,abdominal RaSO2, and on the lateral posterior flank RkSO2
which represent cerebral, intestine, and kidney. Continuous monitoring will be done until
warming phase temperature > 37°C degrees. We can compare cold phase (define) with
warm phase (paired data). Then calculated FTOE for each location as: FTOE = (spO 2
– rSO 2 )/spO 2. We collect clinical characteristics on the day of clinical including heart
rate, blood pressure, urine output, spO 2 , pCO 2, hemoglobin levels, also collected GA,
birth weight, Apgar score, postnatal age, weight, ventilator mode and settings, and
inotrope administration from the patients medical charts.

Closure

Through this research project, we want to thank everyone who helped us with the
idea on this research especially our teacher, family, and colleagues. We strongly hope
PT Binabakti Mitragemilang can provide the support us to realize our research project
“Evaluation of Regional Cerebral, Abdominal and Renal Oxygenation in Unintended
Hypothermic Infants by Using NIRS (Near Infrared Spectroscopy).

Warm regards,

Mahendra Tri Arif Sampurna, dr., SpA

Curriculum Vitae

Contact Details

Lecturer
Paediatrics & Child Health
Soetomo Hospital
University Airlangga
Surabaya
Indonesia

T: +6281230904621
E: [email protected]

Expertise
Neonatal Intensive Care

Biography

Mahendra Tri Arif Sampurna is member of Neonatology staf in the Department of Paediatrics
and Child Health, Soetomo Hospital, Faculty of Medicine Airlangga University. He qualified
from University Airlangga as Pediatrician in 2013, trained in the Women Children Hospital
Harapan Kita Jakarta in 2015, he continued subspeciality training in Neonatology field in Beatrix
Children Hospital University Medical Centrum Groningen (UMCG) the Netherlands (2015-
2016). He returned to Indonesia and worked as a lecturer in Neonatology Division of Pediatric
Department Soetomo Hospital, Airlangga University.

Research Interests

1. Sampurna MTA, Faizi M. Emma N, Harjantien M. Clinical profile congenital

hypothyroidsm in Soetomo Hospital 2000-2010. Pediatrica Indonesiana.
2. Sampurna MTA, Irawan R, Harianto A. Tolerability of glutamine enriched enteral nutrition
In low birth weight infants. Pediatrica Indonesiana
3. Sampurna MTA, Irawan R, Harianto A. Gaining weight pattern of low birth weight infants
supplemented with various dose glutamine enriched enteral nutrition in dr. Soetomo
hospital. Pediatrica Indonesiana.

Key Areas of Interst

1. Neonatal Resuscitation
Manual ventilation, effectiveness of resusucitation training programs, NRP instructor
2. Stabilization and Transportation
 Stabilization in limited resources area and instructor of S.T.A.B.L.E program and
Neonatal Emergency Transport Service (NETS) trained by Ministry health of Indonesia
3. Neonatal Nutrition
Researcher and winner of World Bank Competition foundation for neonatal nutrition
research with title “Gaining weight pattern of low birth weight infants supplemented with
various dose glutamine enriched enteral nutrition”
4. Pain Management in Neonate
Practitioner who introduced neonatal infant pain scale (NIPS) and sucrose as
management pain in Soetomo Hospital.
5. Neonatal Hyperbilirubinemia
Conduct research as a PhD trajectory Program which is supervised by University
Medisch Centrum Groningen the Netherlands. Role as principal investigator.

Professional Activities

Honours and Awards

Year Title Awarding Body

Best Graduation of Comprehensive Obstetric
2014 JNPK-KR
Neonatal Emergency Services
Best Graduation of Indonesian Pediatric
2013 Collegium of Indonesian Child Health
Competention Examination

Training and Symposium

No Events Year
1 Speaker Workshop & Seminar Keperawatan Nasional serta Workshop 2017
PMK, Nganjuk
2 Don Ostrow Triste Yellow Retreat 2017 Program. Italy, Bilimatrix 2017
3 Speaker on Product Launching Carestation GE Healthcare 2017
4 Ayah ASI, Partner Terbaik Ibu Menyusui ( Majalah Kendangsari Merr) 2017
5 2nd Symposium & Workshop Update Neonatal (SWUN) 2017
Fasilitator Workshop Nutrition and Symposium Speaker
6 Pediatrics Academic Societies (PAS) Meeting 2017
6-9 Mei 2017, San Francisco, California
7 9th National Congress of the Indonesian Society for Allergy and 2017
Immunology Early Identification of Allergy and Behavior Problem
In Children
8 The Best of IPOKRaTES : An Update in Neonatology 2016
14-17 November 2016, Singapore
9 Infant Respiratory Symposium 2016
3-4 September 2016, Hilton Tokyo Odaiba 1-9-1 Daiba, Minato,Tokyo
135-8625, Japan
 10 Neonatal Hemodynamic 2016
11 PIT VIII IKA IDAI 2016
12 Workshop UKK Neonatologi “Neonatal Resuscitation” 2016
Pra PIT VII IKA IDAI
13 IN House Training Resusitasi BBL di RSUD Syarifah Ambami Rato Ebu 2016
Bangkalan
14 Pelatihan STABLE NETSS 2016
15 PICU NICU Update 8th 2016
16 KONAS PERINASIA 2016
17 Course and Workshop on Applied Good Clinical Practice (GCP) 2016
– The Indonesian Association for Study of Medicinals (IASMED)
18 IN House Training Penangganan Pada BBLR di RSUD Dr M. SALEH 2015
Probolinggo
19 TOT Helping Babies Breathe AAP – Perinasia 2015
20 Pertemuan Ilmiah Tahunan Ke 7 Ilmu kesehatan Anak Ikatan Dokter 2015
Anak Indonesia
21 Trainer Resuscitation 2015
22 Advance Maternal Neonatal Resuscitation 2015
23 PICU NICU UPDATE 7th 2015
24 1ST ANNUAL NEONATOLOGY UPDATE 2015
25 Symposium Neonatal Service Level II & III 2015
26 Workshop Kangaroo Mother Care 2015
27 SYMPONIC Women Children Hospital Harapan Kita, Jakarta 2015
28 Update Mechanical Ventilation in Newborn 2015
29 Konika XVI Palembang 2015
30 Konika XVI Palembang 2015
31 BREASTFEEDING FRIENDLY PRACTICE 2015
32 LONG TERM EFFECTS OF DHA SUPPLEMENTATIONS ON 2015
CHILDHOOD COGNITIVE OUTCOMES THE FIRST
BRESTFEEDING UPDATE “BREASTFEEDING SICK BABIES”
33 UPDATE NEONATAL RESPIRATORY PROBLEMS (FASILITATOR 2015
KANGAROO MOTHER CARE)
34 UPDATE ON NEONATAL RESPIRATORY PROBLEMS 2015
(SIMPOSIUM NEONATAL SERVICE LEVEL II DAN III)
35 POST SYMPOSIUM WORKSHOP 7th PICU NICU UPDATE 2015
36 PRE SYMPOSIUM WORKSHOP 7th PICU NICU UPDATE 2015
37 Symposium of Nutrition and Brain Development in Sick Newborn Infants 2014
38 Breastfeeding Sick Babies 2014
39 Workshop HFO-Mastering HFO : New Concept In Ventilation Strategy 2014
40 Speaker and Trainer Simposium dan Workshop Update Neonatology 2014
41 Neonatus Life Support 2014
42 Management Nursing Trainer Level I, II, III 2014
43 Neonatal Resuscitation Program by Perinasia 2014
44 Team PONEK 2014
45 Lactation Counselor 2013

Work Experience :
1. Fellowship Neonatology in UMCG, Groningen, the Netherlands 2015-2016
2. Fellowship Neonatology in Women Children Hospital Harapan Kita 2015
3. Staff Neonatology Division Pediatric Department Soetomo Hospital Airlangga University
Surabaya Indonesia from 2013-present
4. Secretary of Conjoined twin center Soetomo Hospital from 2013-present
5. Team of Hydrocephal Soetomo Hospital Surabaya from 2013-present
6. Team Management of Obstetric Neonatal Emergency Comphrehensif Soetomo Hospital
Surabaya from 2013-present
7. Team of Birth Defect Soetomo Hospital Surabaya Indonesia from 2013-present

Surabaya, October 12th 2017

(Mahendra Tri Arif Sampurna, dr., SpA)