A clinical trial on the effect of reducing blood sampling in extremely preterm neonates

Effect of limiting blood sampling losses in early postnatal period in extremely premature neonates- A Randomized controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022964

Enrollment

100

Registered

2020-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: P070- Extremely low birth weight newborn

Interventions

Intervention1: Limited blood sampling group: Three pronged approach to limit blood sampling losses in first 1 month of life,by A-Reducing frequency of sampling B-Reducing volume of blood sampled C-D

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants

Exclusion criteria

Exclusion criteria: 1.Placenta previa, Abruptio placentae, Retroplacental hemorrhage (Concealed hemorrhage) 2.Monochorionic twins/triplets/Quadruplets 3.Rh isoimmunisation 4.Hydrops fetalis 5. Major congenital anomalies in the infant like Gastroschisis, Exomphalos. 6. Extremely sick neonates who are deemed unlikely to survive beyond first 72 hours of life.

Design outcomes

Primary

Measure	Time frame
Need for Packed RBC transfusionsTimepoint: At 6 weeks of postnatal age	—

Secondary

Measure	Time frame
Late onset sepsis ( culture positive) Timepoint: At the time of discharge;All cause mortality Timepoint: At the time of discharge;Bronchopulmonary Dysplasia(Oxygen requirement at 36 weeks) Timepoint: At the time of discharge;Duration of hospital stay (days) Timepoint: At the time of discharge;Duration of respiratory support (days) Timepoint: At the time of discharge;Necrotising enterocolitis (stage 2 or more) Timepoint: At the time of discharge;Need for packed RBC transfusion Timepoint: At the time of discharge;Neurodevelopmental outcomes Timepoint: At 18-24 months of corrected gestational age;Number of transfusions Timepoint: At the time of discharge;Patent ductus arteriosus requiring treatment Timepoint: At the time of discharge;Periventricular LeukomalaciaTimepoint: At the time of discharge;Phlebotomy loss volume Timepoint: At the time of discharge;Retinopathy of prematurity requiring intervention. Timepoint: At the time of discharge;severe Intraventricular haemorrhage(Grade 3 or 4)Timepoint: At the time of discharge;Time to first packed RBC transfusionTimepoint: At the time of discharge;Time to reach full feeds Timepoint: At the time of discharge;Weekly hemoglobin level Timepoint: At the time of discharge	—

Measure

Time frame

Late onset sepsis ( culture positive) Timepoint: At the time of discharge;All cause mortality Timepoint: At the time of discharge;Bronchopulmonary Dysplasia(Oxygen requirement at 36 weeks) Timepoint: At the time of discharge;Duration of hospital stay (days) Timepoint: At the time of discharge;Duration of respiratory support (days) Timepoint: At the time of discharge;Necrotising enterocolitis (stage 2 or more) Timepoint: At the time of discharge;Need for packed RBC transfusion Timepoint: At the time of discharge;Neurodevelopmental outcomes Timepoint: At 18-24 months of corrected gestational age;Number of transfusions Timepoint: At the time of discharge;Patent ductus arteriosus requiring treatment Timepoint: At the time of discharge;Periventricular LeukomalaciaTimepoint: At the time of discharge;Phlebotomy loss volume Timepoint: At the time of discharge;Retinopathy of prematurity requiring intervention. Timepoint: At the time of discharge;severe Intraventricular haemorrhage(Grade 3 or 4)Timepoint: At the time of discharge;Time to first packed RBC transfusionTimepoint: At the time of discharge;Time to reach full feeds Timepoint: At the time of discharge;Weekly hemoglobin level Timepoint: At the time of discharge

—

Countries

India

Contacts

Public ContactDr Vimmi Tripathi

Surya childrens medicare pvt. ltd.

doctorhbk@gmail.com09820457078

Outcome results

None listed

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