Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs

Status Recruiting

Clinical Trial Summary

Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. The data gathered indicate that delayed cord clamping may be particularly useful in premature babies, between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the incidence of intraventricular haemorrhage.

However it is argued that the described potential benefits of delayed cord clamping could be negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by potential interference with the postpartum haemorrhage management, initial care and reanimation of the premature newborn, and the possibility of cord blood donation. These factors, together with as the lack of homogeneity among existing studies regarding the delayed cord clamping technique create the need, in our opinion, for further research, to establish the proper place of this measure.

Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces the need for blood transfusions and intraventricular haemorrhage, compared with usual early cord clamping.

Secondary outcomes:

- To define the impact of delayed cord clamping on neonatal assessment parameters after delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.

- Neonatal mortality and morbidity

- Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage

- To study the correlation between Iron metabolism and reticulocitary haemoglobin levels in cord and infant blood.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Cerebral Hemorrhage
Delayed Umbilical Cord Clamping Benefits
Hemorrhage
Intraventricular Haemorrhage
Postpartum Haemorrhage
Postpartum Hemorrhage

Clinical Trial Details

NCT number	NCT02187874
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact	Melchor Carbonell, MD
Phone	0034626470597
Email	xormd11@gmail.com
Status	Recruiting
Phase	N/A
Start date	July 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early. — CODE-P

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms