RecruitingACTRN12620000195954

Deferred Cord Clamping to Reduce Need for Neonatal Blood Transfusion: the Transfusions In The APTS Newborns Study (TITANS)

Understanding the Role of Deferred Cord Clamping in Reducing Need for Neonatal Red Cell Transfusion: what can be learned from the Australian Placental Transfusion Study? A retrospective, nested, observational study of APTS newborns

Sponsor

University of Sydney

Enrollment

1,401 participants

Start Date

May 15, 2020

Study Type

Observational

Conditions

Pre-term birth

Summary

The Australian Placental Transfusion Study (APTS) and other studies provide strong evidence that deferring umbilical cord clamping at birth for up to a minute is a simple, safe procedure that reduces the proportion of preterm infants who need a blood transfusion by 10%. The mechanism is not fully understood – but one potential mechanism is an increased volume of transfusion of blood from the placenta to the baby after birth. Alternatively, deferred cord clamping may reduce severity of illness in the first weeks after birth. This could lead to fewer blood tests, greater tolerance of anaemia, and better opportunities for babies to make their own red cells. The Transfusions In The APTS Newborns Study (TITANS) is designed is to obtain and analyse more data about the babies in APTS to investigate the mechanism behind the reduced need for red cell transfusions, and to explore whether there are other changes in clinical care that could reduce the need for transfusion.

Eligibility

Sex: Both males and femalesMax Age: 30 Weekss

Plain Language Summary

Simplified for easier understanding

When a premature baby is born, the umbilical cord connects them to the placenta, which still contains a significant volume of blood rich in red cells and nutrients. Clamping the cord immediately (as was once standard practice) cuts this flow off early. Delaying cord clamping by even 30–60 seconds allows more blood to transfer to the baby — and earlier research showed this simple change reduced the need for blood transfusions by 10%. This study, called TITANS, is a follow-up investigation designed to understand exactly why deferred cord clamping reduces transfusion rates. Researchers will analyse existing data from a large previous trial (the Australian Placental Transfusion Study), looking at blood volume, illness severity in early life, and the baby's own ability to produce red cells — to identify the mechanism and find other ways to reduce transfusions further. This study analyses data from babies already enrolled in the Australian Placental Transfusion Study (APTS) at Australian and New Zealand sites, where the original trial is still running. Newborns born at more than 30 weeks gestation who were enrolled in APTS are eligible. APTS participants who withdrew consent are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Data from the APTS study combined with other routinely collected clinical data from APTS Australian and New Zealand sites relating to receipt of transfusion and the factors that affect risk for transfusion in preterm infants during their hospital admission after birth will be used for this study. No additional participant contact is required for the study. Data will be collected from patient medical records.