To study whether bathing newborn babies who are less than or equal to 1500 grams twice weekly with 1 % chlorhexidine is similar in efficacy and safety as compared to 2 % chlorhexidine in the setting of a clinical trial

Non inferiority trial comparing efficacy and safety of biweekly 1% vs 2% chlorhexidine bath in neonates â?¤ 1500 grams: a two arm, blinded, randomised controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043182

Enrollment

180

Registered

2022-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

None listed

Interventions

Intervention1: 1 percent Chlorhexidine: Biweekly bath with 1 % CHlorhexidine in neonates â?¤ 1500 grams till discharge from NICU or death Control Intervention1: 2 percent chlorhexidine: Biweekly bath

Eligibility

Inclusion criteria

Inclusion criteria: 1. 2. 3. Admitted to NICU (neonatal ICU) on or after 15 June 2022 4. No active ongoing sepsis 5. Parents have given informed consent

Exclusion criteria

Exclusion criteria: 1. Major congenital malformation incompatible for life diagnosed or suspected antenatally 2. Skin defects in epidermis involving more than 5% of body due to birth injury or infections or adhesive tape injury. 3. Any baby with suspected or proven or probable sepsis till sepsis has been either ruled out or treated adequately. Once sepsis ruled out or treated, baby will be eligible for inclusion.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of biweekly Chlorhexidine bath with 1% vs 2% CHG in neonates (â?¤ 1500 grams) during entire NICU stay duration in reducing sepsis (proven and probable).Timepoint: Till discharge from NICU	—

Secondary

Measure	Time frame
1. Risk of mortality 2. Skin assessment score assessed once every week 3. Weekly hematocrits, creatinine, AST, ALT 4. Evidence of brain injury on ultrasonography 5. Neurodevelopment assessment 6. Hearing assessment 7. Retinopathy of prematurity (all stages of severity) 8. Retinopathy of prematurity (threshold disease and stages that satisfy treatment threshold as per the early treatment of ROP guidelines of ICROP) 9. Incidence of anaemia 10. Need for blood transfusions 11. Number of blood transfusions 12. Significant hyperbilirubinemia (defined as unconjugated jaundice requiring phototherapy) in the first week of life 13. Severe hyperbilirubinemia (defined as unconjugated jaundice requiring blood exchange transfusion) in the first week of life 14. Duration of phototherapy (in days) 15. Requirement of blood or volume expanders or vasopressors for maintaining blood pressure above 10th percentile for gestational ageTimepoint: Till discharge from NICU or 40 weeks post menstrual age	—

Measure

Time frame

1. Risk of mortality 2. Skin assessment score assessed once every week 3. Weekly hematocrits, creatinine, AST, ALT 4. Evidence of brain injury on ultrasonography 5. Neurodevelopment assessment 6. Hearing assessment 7. Retinopathy of prematurity (all stages of severity) 8. Retinopathy of prematurity (threshold disease and stages that satisfy treatment threshold as per the early treatment of ROP guidelines of ICROP) 9. Incidence of anaemia 10. Need for blood transfusions 11. Number of blood transfusions 12. Significant hyperbilirubinemia (defined as unconjugated jaundice requiring phototherapy) in the first week of life 13. Severe hyperbilirubinemia (defined as unconjugated jaundice requiring blood exchange transfusion) in the first week of life 14. Duration of phototherapy (in days) 15. Requirement of blood or volume expanders or vasopressors for maintaining blood pressure above 10th percentile for gestational ageTimepoint: Till discharge from NICU or 40 weeks post menstrual age

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Countries

India

Contacts

Public ContactPrashant Gupta

Bhagirathi Neotia Women and Child Care Centre, Newtown

bikramjit.wishes@gmail.com9216249740

Outcome results