Observational study of the impact of the timing of cord clamping in healthy neonates.

Observational study of the impact of the timing of cord clamping on cardiovascular parameters in healthy neonates.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000485437

Acronym

TOCC2

Enrollment

100

Registered

2016-04-13

Start date

2016-03-01

Completion date

2017-11-01

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

In the womb, blood flows to and from the baby through blood vessels in the umbilical cord which connects the placenta (lining of the womb) to the developing baby (fetus). After the birth of a baby blood continues to flow back and forth whilst the umbilical cord remains unclamped allowing some remaining blood from the placenta to flow to the baby. It is routine to clamp and cut the cord after birth. At present, we do not know the ideal time for the umbilical cord to be left unclamped and uncut. The aim of our study is to find out how cord clamping affects the normal adaptation a newly born baby has to make in adjusting circulation of their blood and their breathing patterns and effort. We intend to do this by measuring newly born babies oxygen saturation levels and their heart rate using a monitor (pulse oximeter) we use routinely in the nursery. We know that it takes a few minutes after birth for babies to adapt to life outside the womb and would like to document the changes in oxygen levels and heart rate in the first 10 minutes after birth and to investigate if the timing of cord clamping affects these values. This information will help us to determine the best time to cut the umbilical cord. What the study involves: We place a pulse oximeter sensor on a baby’s right hand, and for some infants place 3 sensors on their chest to measure heart rate) In a small subgroup of infants we will place sensors on the babies head to measure cerebral oxygenation. As soon as possible after a baby is born and while she/he is on their mother’s chest we dry baby’s hand and place the sensor on their right hand. We can do this without disturbing parents from cuddling their new baby. It does not interfere with the midwife caring for the women whilst waiting for the placenta to be delivered. The sensor on a baby’s hand stays in place for the first 10 minutes after baby’s birth. The researchers do not interfere with the normal care given to a newly born baby. Our aim is to combine measurements from many babies to get a picture of what happens to oxygen levels and heart rate in normal healthy babies in the first minutes after their birth.

Interventions

This is an observational study measuring and recording physiological parameters (HR, SpO2, rSO2) in the first 10 minutes after birth of newborn infants. Infants are followed until discharge home. For each study infant the timing of cord clamping is decided by the treating midwife as per standard care protocol, and is not controlled as part of this study.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Any infant greater than or equal to 32 weeks’ gestation up to a maximum gestational age of 42 week gestation and enrolled prior to their birth at RWH is eligible for inclusion. Only infants born vaginally are eligible.

Exclusion criteria

1. Multiple birth 2. Nuchal cord requiring division before birth of the infant 3. Vasa praevia 4. Planned lotus birth 5. Planned water birth 6. Planned cord blood donation

Outcome results