Efficacy of Caffeine Vs, Theophylline In The Prevention of Acute Kidney Injury In Term, Asphyxiated Newborn – A Randomized Comparative Open Labelled Non Inferior Study..

Abstract

INTRODUCTION: Asphyxia is the most common cause of convulsion in newborns, associated with high mortality and morbidity. It is a multisystem disorder involving many organs, but the effects on the heart, brain, and kidney are pronounced. It can involve kidneys and cause renal injury, which presents with oliguria and sometimes anuria in the newborn. Urine output and serum creatinine levels are usually difficult to monitor in newborn babies. Term newborn usually do not pass urine till 48 hrs and their serum creatinine levels are usually a reflection of maternal serum creatinine levels, hence cannot be used as a reliable indicator for monitoring of AKI in the newborn as this can give rise to a false positive error. Cystatin C is a more sensitive and specific marker for assessing kidney injury in the newborn. Hence, for this reason, cystatin C is used for monitoring of renal injury in newborn. For prophylactic prevention of AKI, a single dose of theophylline of 8mg/kg is given to the newborn, but it can be toxic and also can cause seizures and can even cause difficulty in the monitoring of asphyxia, so as alternative caffeine can be tried to prevent AKI in term and preterm babies as it is safer and does not cause seizures in the newborn. Caffeine is commonly used in premature infants, and its use in term infants is not documented. Hence, we are using caffeine as a drug to prevent AKI in the newborn. To the best of our knowledge, this study is the first of its kind using both caffeine and theophylline in the prevention of AKI in the asphyxiated term newborn. Caffeine has the same role as theophylline, but being a drug with minimal or no CNS side effects DocuSign Envelope ID: 592DBFA138FD3A3D-6-2EBEA15-4-4968E9E-8-298D08-1E-C7A8A314D45D26D79B12CA7 xii like irritability or convulsions, as can occur with theophylline use, it is an appropriate choice for prevention of AKI in asphyxia in term and preterm neonate. OBJECTIVES: The purpose of this study is to compare the use of theophylline and caffeine in the asphyxiated babies and compare the renal parameters like creatinine with cystatin C in the term, late preterm & low birth weight neonates admitted in NICU. MATERIAL AND METHODS: Sample for the study are all term, late preterm & low birth weight neonates admitted in NICU with birth asphyxia at Shri B. M. Patil Medical College, Hospital & Research Centre, Vijayapur. Neonates were randomly allotted into two groups. In Group-A, caffeine was used, and in Group-B, theophylline was given. RESULTS: A total of 100 patients with clinically confirmed Birth asphyxia were randomly allotted into 2 groups with 50 patients in each group. Mortality was more in theophylline group with death of 2 patients(4%), and in caffeine group death was only in 1 patients(2%) with P value of 0.634. Both groups were comparable and had equal severity of BA as all parameters like sex distribution (P-value:0.677), birth weight (P-value: 0.476), GA (p =0.887), inborn (p=0.309), gravidity (p=0.548), mode of delivery (p=0.663), MBG (p=0.157). Resuscitation measures (p=0.031), treatment given (p<0.001), therapeutic hypothermia (p= 0.307), HIE staging (p=0.017), NICU stay (p=0.036). (cystatin C on day 1 is significant (p=0.005).) DocuSign Envelope ID: 592DBFA138FD3A3D-6-2EBEA15-4-4968E9E-8-298D08-1E-C7A8A314D45D26D79B12CA7 xiii CONCLUSION: In my study, caffeine and theophylline given in asphyxiated newborn, the results of caffeine group were comparable to that of caffeine, caffeine group babies had lower cystatin C levels at day 3 as compared to theophylline, also the babies of caffeine group had a better outcome.