Mohamed Sajjid, (2013) A Randomized Controlled Trial of Fluid Supplementation in Term Neonates with Severe Hyperbilirubinemia with N/3 (0.3%) Saline in 5% Dextrose. Masters thesis, Madras Medical College, Chennai.
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Abstract
INTRODUCTION: Hyperbilirubinemia is a very common problem in the neonates with an overall incidence of 70-80%. It occurs due to the deposition of bilirubin released from breakdown of RBCs and from other non-heme sources in the skin and mucus membranes of the newborn. It is more common in preterm babies than full term newborns. In the majority of cases jaundice is mild and transient. 5-10% of the newborns develop clinically significant jaundice requiring intervention. Neonatal jaundice remains one of the most common reasons for readmission to hospital during the first week of life. AIMS AND OBJECTIVES: To compare the efficacy of supplemental fluid therapy in term/AGA babies with high levels of non-haemolytic hyperbilirubinemia with N/3 saline in 5% dextrose versus control in preventing blood exchange transfusion (BET). METHODOLOGY: Study Centres: Department of Neonatology, Institute of Child Health (extramural unit) and Institute of Obstetrics and Gynaecology (intramural unit) of Madras Medical College, Chennai, Tamilnadu, India. Duration of the Study: April 2012 to March 2013. Study Design: Prospective randomized controlled trial. Materials & Methods: Subjects: Neonates with severe hyperbilirubinemia with serum bilirubin >20mgs/dL admitted to the newborn wards of the Institute of Child Health and Institute of Obstetrics & Gynecology Egmore, tertiary care hospitals in Chennai, India. Inclusion Criteria: Term (≥37 weeks gestation)/AGA neonates presenting with severe non- hemolytic hyperbilirubinemia (total serum bilirubin [TSB] >20 mg/dL and ≤25mg/dL. Exclusion Criteria: 1. Infants with TSB >25mg/dL (427 mmol/L). 2. Acute bilirubin encephalopathy (kernicterus). 3. Evidence of hemolysis (Coombs test positive, peripheral blood smear demonstrating evidence of hemolysis or reticulocyte count was > 6%). 4. Obvious signs of dehydration (i.e., sunken fontanel, reduced skin turgor, dry mucosa, tachycardia, delayed capillary refill, excessive weight loss). 5. Major congenital malformations. 6. Infants already receiving intravenous (IV) fluids for any reason. Sample Size: A pilot study carried out at the Institute of Child Health in 16 babies with severe hyperbilirubinemia (serum bilirubin >20 mg/dL and ≤25mg/dL) with 7 babies in the interventional group and 9 babies in the control group. 1 baby in the interventional group (14%) and 6 babies in the control group (66%) required blood exchange transfusion by the predefined criteria which amounted to a difference of more than 50%. To detect a 50% difference in the need for exchange transfusion with 95% confidence (α = 0.05) and 80% power (β = 0.2), 84 infants (42 in each group) were needed. Hence 84 infants were enrolled in the study after randomization. CONCLUSIONS: 1. The IV fluid supplementation with 0.3% saline in 5% dextrose in newborns with severe non-hemolytic hyperbilirubinemia was useful in significantly reducing the need for blood exchange transfusion. (p = 0.001) 2. In addition the total duration of phototherapy reduced significantly in the fluid supplementation group (p = 0.013). 3. More percentage drop in serum bilirubin was observed in the fluid supplementation group at 4, 8 and 24 hrs of study (p = 0.001, 0.001 and 0.049). 4. Moreover the use of 0.3% saline in 5% dextrose as fluid for supplementation did not lead to any significant disturbances in sodium homeostasis in the form of hyponatremia or hypernatremia at 8 and 24 hours of study, which could be detrimental to the neonates. (p = 0.767 and 0.419). N/3 (0.3%) saline in 5% dextrose appears to be the ideal fluid of choice for fluid supplementation in term neonates with non-hemolytic severe hyperbilirubinemia. To conclude, this study reinforces the effectiveness of IV fluid supplementation in full term neonates with severe non-hemolytic hyperbilirubinemia in reducing the rate of blood exchange transfusion and the duration of phototherapy and further adds a new dimension regarding the usefulness of 0.3% saline in 5% dextrose as supplementary fluid of choice in maintaining the sodium homeostasis.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No.16103005 |
| Uncontrolled Keywords: | Fluid Supplementation, Term Neonates, Severe Hyperbilirubinemia, N/3 (0.3%) Saline, 5% Dextrose. |
| Subjects: | MEDICAL > Neonatology |
| Depositing User: | Kambaraman B |
| Date Deposited: | 13 Jan 2020 03:46 |
| Last Modified: | 13 Jan 2020 03:46 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/11811 |
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