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

Phase 2/3

Completed

Conditions: Other disorders of bilirubin metabolism,

Registration Number: CTRI/2023/02/049596

Lead Sponsor: Prof Asim Kumar Mallick

Brief Summary: It has to be noted that in the treatment of neonatal hyperbilirubinemia there are few expensive solutions which is a very hard to make available in a primary healthcare setting. Giving the fact that majority of the Indian population depends on the primary or secondary healthcare setting, proper treatment of neonatal hyperbilirubinemia which is significantly prevalent of our country is limited. The successful outcome of this proposed trial is expected to replace expensive phototherapy and reduce the possibility of exchange even in tertiary health care setting. Low cost of the pharmaceutical intervention is also needed to make the treatment of the prevalent neonatal condition available in primary health care or in fragile point of care settings. The present study examines the efficacy of manganese citrate, a FSSAI approved food supplement which is safe for neonatal subject [FSSAI approved Supplement registered under standards of foods for infant nutrition (Schedule I(a), 11.3) & health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food (Schedule â€“ I B, 8(iii)] to degrade bilirubin during *in vivo* oral administration in human patients with neonatal hyperbilirubinemia., The purpose of this proof-of-concept trial is to assess the efficacy of manganese citrate along with pharmacokinetics (PK) and pharmacodynamics (PD) of bilirubin by oral administration of manganese citrate in 196 patients with neonatal hyperbilirubinemia A randomized double blinded phototherapy controlled crossover clinical trial to compare the efficacy of Manganese citrate in neonatal hyperbilirubinemia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 196

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.

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

Primary Outcome Measures

Name	Time	Method
Outcome Name: Total Serum Bilirubin concentration in blood	2 hours, 4 hours, 6 hours

Secondary Outcome Measures

Name	Time	Method
Outcome Name: Total Serum Bilirubin concentration in blood	12 hours, 18 hours, 24 hours, 30 hours

Trial Locations

Locations (1): Nil Ratan Sircar Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Nil Ratan Sircar Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Prof Asim Kumar Mallick
Principal investigator
9830008057
nrsprojectdrmallick2021@gmail.com