A clinical trial to study the effect of Manganese citrate in neonates with hyperbilirubinemia

Phase 2

Completed

• Conditions: Health Condition 1: E806- Other disorders of bilirubin metabolism

• Registration Number: CTRI/2023/02/049596
• Lead Sponsor: Prof Asim Kumar Mallick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-03-10
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

Inclusion criteria comprised of all the neonates irrespective of the gestational age admitted to the Department of Paediatric Medicine, NRSMH with or without jaundice and those requiring phototherapy to monitor the reduction of bilirubin concentration in the blood with response to the phototherapy.

Neonates with neonatal hyperbilirubinemia associated with birth asphyxia. Birth asphyxia is defined if there is presence of at least one of the following condition:

A.Gasping or ineffective breathing or lack of breathing at one minute of life

B.Need for positive pressure Ventilation for >1minute

C.Apgar score <3 at 5 minutes or longer

[according to the definition mentioned in Facility Based Newborn Care by Government of India].

Neonates with neonatal hyperbilirubinemia associated with ABO incompatibility. ABO incompatibility is defined if there was a mismatch between the blood groups of mother and the newborn.

Neonates with neonatal hyperbilirubinemia associated with Rh incompatibility. Rh incompatibility is defined if there was a mismatch between the Rh factors of mother and the newborn.

Neonates with neonatal hyperbilirubinemia associated with G6PD deficiency. G6PD deficiency is defined if G6PD levels in blood was <4.6 U/gm haemoglobin.

Exclusion Criteria

Neonates suffering from Sepsis (defined as a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteraemia in the first week of life.); not suffering from neonatal bilirubinemia, and other co-morbities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified