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

A randomized double blinded phototherapy controlled crossover clinical trial to compare the efficacy of Manganese citrate in neonatal hyperbilirubinemia.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049596
Enrollment
196
Registered
2023-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E806- Other disorders of bilirubin metabolism

Interventions

Intervention1: Manga Nano (Brand Name) or Manganese Citrate (Generic Name): The intervention being studied is called Manga Nano (Brand Name) or Manganese Citrate (Generic Name), branded by the compa

Sponsors

Prof Asim Kumar Mallick
Lead Sponsor

Eligibility

Inclusion criteria

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 [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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Outcome Name: Total Serum Bilirubin concentration in bloodTimepoint: 2 hours, 4 hours, 6 hours

Secondary

MeasureTime frame
Outcome Name: Total Serum Bilirubin concentration in bloodTimepoint: 12 hours, 18 hours, 24 hours, 30 hours

Countries

India

Contacts

Public ContactProf Dr Samir Kumar Pal

Chemical, Biological and Macromolecular Sciences, S.N.Bose National Centre for Basic Sciences

skpal@bose.res.in9331295025

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026