Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000485437
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
13/04/2016
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Observational study of the impact of the timing of cord clamping in healthy neonates.
Scientific title
Observational study of the impact of the timing of cord clamping on cardiovascular parameters in healthy neonates.
Secondary ID [1] 288893 0
none
Universal Trial Number (UTN)
Trial acronym
TOCC2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transition from fetal to extra-uterine life 298198 0
Condition category
Condition code
Reproductive Health and Childbirth 298467 298467 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 294348 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297831 0
Heart rate measured by a Masimo pulse oximeter with the sensor sited on the infant's right hand or wrist.
Timepoint [1] 297831 0
Heart rate is measured continuously with the pulse oximeter for the first ten minutes after birth.
Primary outcome [2] 297832 0
Oxygen saturation measured by a Masimo pulse oximeter with the sensor sited on the infant's right hand or wrist.
Timepoint [2] 297832 0
Oxygen saturation is measured continuously with the pulse oximeter for the first ten minutes after birth
Primary outcome [3] 297836 0
In a random subgroup of 100 infants we will use an Invos monitor with near infrared spectroscopy (NIRS) to continuously measure cerebral oxygen saturation (rSO2) of blood for the first 10 minutes after birth. a small sensor will be sited on the infant's forehead to obtain these measurements.
Timepoint [3] 297836 0
Regional cerebral oxygenation will be measured continuously for the first 10 minutes after birth.
Secondary outcome [1] 322364 0
We will use pulse oximeter measurements of heart rate to calculation the proportion of infants who are bradycardic (HR <90bpm) at 90s after birth
Timepoint [1] 322364 0
90s after birth
Secondary outcome [2] 322365 0
The researcher present at the birth will record the time from birth (seconds) that it takes for an infant to give their first cry.(seconds)
Timepoint [2] 322365 0
Seconds after birth
Secondary outcome [3] 322366 0
The researcher present at the birth will record any active resuscitation given to a study infant including administration of continuous positve pressure (CPAP), intermittent positive pressure ventilation (PPV) endotracheal intubation
Timepoint [3] 322366 0
Active resuscitation in the first ten minutes after birth
Secondary outcome [4] 322367 0
The researcher attending the birth will ask the attending midwife to calculate the Apgar score.
Timepoint [4] 322367 0
One, five and ten minutes after birth
Secondary outcome [5] 322368 0
We will document addmission to a special care or intensive care nursery.
Timepoint [5] 322368 0
First 36 hours after birth or until the infant is discharged home
Secondary outcome [6] 322369 0
Length of the third stage of labour is calculated by the attending midwife. We will obtain this information from the medical record.
Timepoint [6] 322369 0
Minutes after the birth of the infant

Eligibility
Key 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.
Minimum age
0 Hours
Maximum age
0 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
In this observational study with a convenience sample of 470 infants we want to describe HR (Dawson et al Arch Dis Child Fetal Neonatal Ed 2010 May;95(3):F177-81). and SpO2 (Dawson et al Pediatrics. 2010 Jun;125(6):e1340-7) centiles in newly born infants. In our previous study we obtained data from 429 infants >=32 weeks’ gestation to construct HR and oxygen centiles. Many of the babies in the first study were born following early cord clamping. In the current study we will recruit a similar number of infants to allow for comparisons between the previous and current study. To account for post enrollment exclusions (for example an obstetric emergency or the need for neonatal resuscitation), an additional 10% will be enrolled.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
31/03/2018
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
470
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5528 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 13000 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 293247 0
Hospital
Name [1] 293247 0
The Royal Women's hospital
Country [1] 293247 0
Australia
Primary sponsor type
Individual
Name
Dr Jennifer Dawson
Address
Newborn Research
The Royal Women's Hospital
Cnr Flemington Road and Grattan Street
Parkville, Melbourne, 3052
Victoria
Country
Australia
Secondary sponsor category [1] 292049 0
None
Name [1] 292049 0
none
Address [1] 292049 0
none
Country [1] 292049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294725 0
The Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 294725 0
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville, Victoria, 3052
Ethics committee country [1] 294725 0
Australia
Date submitted for ethics approval [1] 294725 0
25/01/2016
Approval date [1] 294725 0
17/02/2016
Ethics approval number [1] 294725 0
13/44

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 835 835 0 0
/AnzctrAttachments/370443-Dawson 2010 Oxygen reference range.pdf
Attachments [2] 836 836 0 0
/AnzctrAttachments/370443-Dawson heart rate centiles 2010.pdf

Contacts
Principal investigator
Name 64830 0
Dr Jennifer Dawson
Address 64830 0
Newborn Research
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville, Victoria, 3052
Country 64830 0
Australia
Phone 64830 0
+61 3 8345 3791
Fax 64830 0
Email 64830 0
[email protected]
Contact person for public queries
Name 64831 0
Dr Jennifer Dawson
Address 64831 0
Newborn Research
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville, Victoria, 3052
Country 64831 0
Australia
Phone 64831 0
+61 3 8345 3791
Fax 64831 0
Email 64831 0
[email protected]
Contact person for scientific queries
Name 64832 0
Dr Omar Kamlin
Address 64832 0
Newborn Research
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville, Victoria, 3052
Country 64832 0
Australia
Phone 64832 0
+ 61 3 8345 3763
Fax 64832 0
Email 64832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
not decided


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.