Brief resume of the intended work




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6.



7.

8.


BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

Perinatal hypoxia is one of the most common primary cause of mortality(28%) and morbidity among neonates in India and is the commonest cause of still birth1. An APGAR score of less than 7 at one minute and at

5 minutes is seen in 8.4% and 2.45% cases in India1.

Hyponatremia and hypocalcemia develops early and simultaneously and the decrease in their serum values is directly proportional to each other and to the degree of asphyxia.1,6-8

Hypoxia and ischemia can cause damage to almost every tissue and organ of the body. Kidney is involved in 50%, brain is involved in 28%, heart in 25% and lungs in 23% cases as they are very sensitive to oxygen deprivation2.

Acute renal failure is a recognized complication in birth asphyxia with non oliguric renal failure being most common type and renal insufficiency may occur within 24hrs of hypoxic ischemic episodes. Early recognition of renal failure is important in babies with hypoxic ischemic encephalopathy to facilitate appropriate fluid and electrolyte management as a stable biochemical milieu is vital and any deviation of electrolyte from their normal values in blood might cause convulsions, shock and other types of metabolic abnormalities2.

Renal involvement being a frequent complication in neonates with perinatal asphyxia and it correlates well with neurologic severity5.

This study is undertaken to determine the occurence of renal failure in birth asphyxia and to correlate the severity of renal failure with APGAR score and hypoxic ischemic encephalopathy grading of asphyxiated neonates as there are very few studies done.

6.2 REVIEW OF LITERATURE

A study conducted by Pallab Basu and co-workers1 concluded that babies with perinatal asphyxia developed hyponatremia and hypocalcemia simultaneously soon after birth in proportion to severity of asphyxia. Hyponatremia and hypocalcemia developed early and simultaneously and the decrease in their serum values is directly proportional to each other and to the degree of asphyxia. There is a strong positive linear correlation between serum sodium, serum calcium and their apgar scores and negative linear correlation between apgar scores and serum potassium levels.

A study conducted by B D Gupta and his co-workers2 concluded that blood urea and creatinine were significantly higher and serum sodium levels were lower in asphyxiated neonates as compared to normal neonates, biochemical derangements correlated well with hypoxic ischemic encephalopathy staging and Apgar scores and severity of renal function abnormality correlates well with degree of asphyxia. Mean fractional excretion of sodium was 0.6+0.56% in asphyxiated neonates as compared 0.29+0.27% in controls. 11.4% of asphyxiated neonates developed both hematuria and proteinuria while only 10% developed hematuria alone and babies with hypoxic ischemic encephalopathy I or III had more urinary abnormalities.

Zulfiquar Ali Mangi and his co-workers3 found that severity of renal function correlates well with degree of hypoxic ischemic encephalopathy. They found a rise in concentration of blood urea and creatinine as hypoxic ischemic encephalopathy staging of neonates progressed and difference was statistically significant between babies of hypoxic ischemic encephalopathy I and those with hypoxic ischemic encephalopathy III, as well as severity of acute renal failure correlated well hypoxic ischemic encephalopathy staging and apgar scoring.

Jayashree G and colleagues4 found that 43% developed acute renal failure and a significant correlation was seen between hypoxic ischemic encephalopathy and acute renal failure .

Nouri S and colleagues5 concluded that renal failure correlated with severity of hypoxic ischemic encephalopathy and renal failure is seen in 75% of babies with hypoxic ischemic encephalopathy.

A study conducted by Deepak Jajoo and co-workers6 found that asphyxiated babies had significantly lower serum calcium levels.

A study conducted by Illves P7 found that hyponatremia in 38% and hypocalcemia in 23% of asphyxiated newborns, calcium and sodium derangements are a frequent finding in asphyxiated newborns.

According to Victor Y. H. Yu8 perinatal hypoxia is associated with decreased serum calcium levels.



6.3 OBJECTIVES OF THE STUDY:


  1. To study electrolyte status and renal parameters in asphyxiated newborns of different severity in early neonatal period.

  2. To determine the occurence of renal failure in asphyxiated neonates and to correlate severity with Apgar score and Hypoxic ischemic encephalopathy grading of neonates.

  3. To correlate the levels of serum sodium, potassium and calcium levels with different severity of asphyxia.

MATERIAL AND METHODS

    1. SOURCE OF DATA :

Term, appropriate for gestational age babies born / admitted to NICU of

Fr Muller Medical College Hospital with birth asphyxia during study period.



Type of study : Case Control study.

Duration of study : 1 – 11/2 year.

Sample size and Sampling technique: A sample size of 30 term, appropriate for gestational age babies with birth asphyxia and 15 normal newborns without asphyxia will be selected with purposive sampling technique based on inclusion and exclusion criteria.

    1. METHOD OF COLLECTION OF DATA:

30 newborn term, appropriate for gestational age babies born / admitted to NICU of Fr Muller Medical College Hospital with birth asphyxia during study period and 15 normal newborn babies without birth asphyxia are included in the study.

At the time of enrolment an informed written consent would be obtained from the parents. Detailed perinatal history is obtained from hospital records. Detailed clinical examination will be done. Newborns identified as appropriate for gestational age by applying Ballard’s score and by percentile chart. Diagnosis of birth asphyxia by APGAR score and children with Hypoxic ischemic encephalopathy are staged by SARNAT and SARNAT staging. Gestational age, birth weight, relevant perinatal history, findings on physical examination and systemic examination are recorded on predesigned proforma. Equal number of neonates with mild, moderate and severe birth asphyxia are included in study. Renal function parameters – urine output, urine analysis, urine sodium and creatinine and serum electrolytes with serum calcium will be monitored initially within 24hrs of birth. At 48hrs and 72hrs in addition, blood urea and creatinine will be measured. Fractional excretion of sodium and renal failure index is calculated to determine pre-renal or intrinsic renal failure. Ultrasonography would be performed to detect congenital renal anomalies.

Acute renal failure is defined as serum creatinine of level >1.0 mg/dl on day3 of life and/or urine output of < 1.0ml/kg/hour.

On the basis of apgar score at 5 minutes the asphyxiated babies are grouped into mild(score of 6-7), moderate(score of 4-5) and severe asphyxia(score of 3 or less).



Statistical analysis:

Collected data will be analysed by Unpaired and Paired ‘t’ test, Karl Pearson co-relational coefficient and by chi square test.



INCLUSION CRITERIA:

1. Term, appropriate for gestational age, newborns with history of birth asphyxia.

2. Evidence of neurologic abnormalities suggestive of Hypoxic ischemic encephalopathy.

EXCLUSION CRITERIA:

1. Congenital abnormalities of kidneys and/or urinary tract.

2. Babies with septicemia, respiratory distress syndrome.


  1. Neonates who have received aminoglycoside antibiotics and aminophylline.

  2. Pre term babies with birth asphyxia.

    1. Does study require any investigations or interventions to be conducted on patients or other human or animals? If so please describe briefly.

Yes, blood and urine investigations are carried out to assess the renal functions.

Ultrasonography will be done in all babies.



7.4 Has the ethical clearance been obtained from your institution in case of

7.3?


Yes.

LIST OF REFERENCES

1. Basu P, Som S, Das H and Choudhuri N “Electrolyte status in Birth Asphyxia” Indian Journal of Pediatrics : 2010; 77 : 259 - 262.

2. Gupta B D, Sharma P, Bagla J, Parakh M and Soni J P “Renal Failure in Asphyxiated Neonates”, Indian Pediatrics : 2005 ;42 : 928 - 934.

3. Mangi Z A and colleagues “Birth asphyxia relation between hypoxic ischemic encephalopathy grading and development of acute renal failure in indoor term neonates at Chandka Medical College Children Hospital Larkana”, Medical Channel: Oct - Dec 2009 : 148 - 152.

4. Jayashree G , Dutta A K, Sarna M S, Saili A “Acute renal failure in asphyxiated newborns” Indian Pediatrics 1991 : Vol 28 ; 19 - 23.

5. Nouri S and colleagues “Acute renal failure in full term neonates with perinatal asphyxia” Arch Pediatr 2008 Mar; 15(3) : 229-35.

6. Jajoo D, Kumar A, Shankar R and Bhargava V “Effect of birth asphyxia on serum calcium levels in neonates” Indian Journal of Pediatrics: 1995; 65: 455-459.

7. Ilves P “Serum total magnesium and ionized calcium concentration in asphyxiated newborn with hypoxic ischemic encephalopathy” Acta Paediatrica 2000 : Vol 89(6) : 680-685.



8. Victor .Y .H .Yu “Management of perinatal asphyxia and assessment of long term prognosis” Perinatology 1999: Vol 1(5): 251-266.



9.


SIGNATURE OF THE CANDIDATE:






10.

REMARKS OF THE GUIDE:





11.

NAME AND DESIGNATION OF THE

11.1 GUIDE:


Dr Anil Shetty

Asso. Prof, Dept of Paediatrics

Fr. Muller Medical College

Kankanady,

Mangalore – 575002




11.2 SIGNATURE :









11.3 CO-GUIDE:








11.4 SIGNATURE:









11.5 HEAD OF THE DEPARTMENT:

Dr. K. Varadaraj Shenoy

Prof and HOD, Dept of Pediatrics

Fr. Muller Medical College

Kankanady,

Mangalore – 575002




11.6 SIGNATURE:





12.

12.1REMARKS OF THE CHAIRMAN & PRINCIPAL:







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12.2 SIGNATURE:

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