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Trial registered on ANZCTR


Registration number
ACTRN12619001305112
Ethics application status
Approved
Date submitted
25/09/2019
Date registered
25/09/2019
Date last updated
9/09/2020
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of cord management strategies at preterm birth: a review
Scientific title
Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP)
Secondary ID [1] 299396 0
nil known
Universal Trial Number (UTN)
Trial acronym
iCOMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preterm birth 314566 0
Condition category
Condition code
Reproductive Health and Childbirth 312907 312907 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
Cord management strategies to influence umbilical flow and placental transfusion, including, but not limited to:
• Short deferral of cord clamping (more than 15 to less than 45 seconds) without milking
• Medium deferral of cord clamping (more than or equal to 45 to less than 90 seconds) without milking
• Long deferral of cord clamping (more than or equal to 90 seconds) without milking
• Cord milking or stripping before immediate cord clamping
• Cord milking or stripping before deferred cord clamping
• Cord milking or stripping after immediate cord clamping
• Cord milking or stripping after deferred cord clamping
• Physiological clamping (clamping after aeration of lungs)
Duration of follow-up varies across included trials, but may be up to 2 years.
Intervention code [1] 315648 0
Not applicable
Comparator / control treatment
Immediate cord clamping without milking (less than or equal to 15 sec or trialist defined)
Control group
Active

Outcomes
Primary outcome [1] 321506 0
Infant death
Timepoint [1] 321506 0
hospital discharge
Secondary outcome [1] 375151 0
Infant death
Timepoint [1] 375151 0
at any time during follow-up (duration of follow-up varies across trials, but may be up to 2 years)
Secondary outcome [2] 375152 0
Severe intraventricular haemorrhage on cranial ultrasound (grade 3-4)
Timepoint [2] 375152 0
neonatal (varies depending on trial)
Secondary outcome [3] 375153 0
All grades of intraventricular haemorrhage on cranial ultrasound
Timepoint [3] 375153 0
neonatal (varies depending on trial)
Secondary outcome [4] 375154 0
Necrotizing enterocolitis more than or equal to grade 2
Timepoint [4] 375154 0
neonatal (varies depending on trial)
Secondary outcome [5] 375155 0
Late onset sepsis in infant (where possible defined as clinical sepsis more than 72 hours after birth)
Timepoint [5] 375155 0
neonatal (varies depending on trial)
Secondary outcome [6] 375156 0
Patent ductus arteriosus requiring medical treatment only (trialist defined)
Timepoint [6] 375156 0
neonatal (varies depending on trial)
Secondary outcome [7] 375157 0
Chronic lung disease (at 36 weeks postmenstrual age or trialist defined)
Timepoint [7] 375157 0
at 36 weeks postmenstrual age or trialist defined
Secondary outcome [8] 375158 0
Infant death
Timepoint [8] 375158 0
within 7 days of birth
Secondary outcome [9] 375159 0
white matter brain injury (other than IVH) (as collected in trial)
Timepoint [9] 375159 0
neonatal (varies depending on trial)
Secondary outcome [10] 375160 0
Provision of any respiratory support, as collected in each trial, e.g .mechanical ventilation, CPAP, nasal oxygen, supplemental oxygen
Timepoint [10] 375160 0
neonatal (varies depending on trial)
Secondary outcome [11] 375161 0
Duration of any respiratory support
Timepoint [11] 375161 0
neonatal (varies depending on trial)
Secondary outcome [12] 375162 0
Provision of supplemental oxygen at 36 weeks
Timepoint [12] 375162 0
36 weeks postmenstrual age (PMA)
Secondary outcome [13] 375163 0
Retinopathy of prematurity (trialist defined)
Timepoint [13] 375163 0
neonatal (varies depending on trial)
Secondary outcome [14] 375164 0
Drug treatment for hypotension (as collected in each trial)
Timepoint [14] 375164 0
neonatal (varies depending on trial)
Secondary outcome [15] 375165 0
Number and volume of any infant blood transfusions
Timepoint [15] 375165 0
neonatal (varies depending on trial)
Secondary outcome [16] 375166 0
Infant temperature on admission (as measured in each trial)
Timepoint [16] 375166 0
admission
Secondary outcome [17] 375167 0
Polycythaemia (trialist defined)
Timepoint [17] 375167 0
neonatal (varies depending on trial)
Secondary outcome [18] 375168 0
Jaundice requiring treatment
Timepoint [18] 375168 0
neonatal (varies depending on trial)
Secondary outcome [19] 375169 0
Birthweight
Timepoint [19] 375169 0
at birth
Secondary outcome [20] 375170 0
Highest bilirubin measurement after birth
Timepoint [20] 375170 0
neonatal (varies depending on trial)
Secondary outcome [21] 375171 0
Length of hospital stay
Timepoint [21] 375171 0
at hospital discharge
Secondary outcome [22] 375172 0
Admission to NICU/SCU
Timepoint [22] 375172 0
in the neonatal period
Secondary outcome [23] 375173 0
Length of stay (LOS) in Neonatal Intensive Care Unit (NICU)/ Special Care Unit (SCU)
Timepoint [23] 375173 0
at discharge from NICU/SCU
Secondary outcome [24] 375174 0
Long term developmental disability (assessed using the Bayley III, and/or other tools):
- cerebral palsy
- neurodevelopmental disability
- score on cognitive scale, language scale, social/emotional scale, motor scale, behavioural scale
- deafness
- blindness
Timepoint [24] 375174 0
varies depending on trial, up to 2 years of age
Secondary outcome [25] 375175 0
Apgar scores at 1 and 5 min
Timepoint [25] 375175 0
1 min and 5 min post birth
Secondary outcome [26] 375176 0
Maternal death
Timepoint [26] 375176 0
at birth
Secondary outcome [27] 375177 0
Postpartum haemorrhage (trialist defined)
Timepoint [27] 375177 0
postpartum
Secondary outcome [28] 375178 0
Maternal sepsis requiring treatment (trialist defined)
Timepoint [28] 375178 0
antenatal, intrapartum and postnatal
Secondary outcome [29] 375179 0
Manual removal of placenta (trialist defined)
Timepoint [29] 375179 0
at birth
Secondary outcome [30] 375180 0
Retained placenta (trialist defined)
Timepoint [30] 375180 0
at birth
Secondary outcome [31] 375181 0
Number/volume of maternal blood transfusions
Timepoint [31] 375181 0
at birth
Secondary outcome [32] 375182 0
Incidence of any breastfeeding when baby discharged from hospital
Timepoint [32] 375182 0
at baby discharge
Secondary outcome [33] 375183 0
Postnatal depression (trialist defined)
Timepoint [33] 375183 0
postnatal
Secondary outcome [34] 375184 0
Estimated maternal blood loss volume at delivery
Timepoint [34] 375184 0
at delivery
Secondary outcome [35] 375185 0
Infant haemoglobin level at first measurement after birth
Timepoint [35] 375185 0
first measurement after birth (varies depending on trial)
Secondary outcome [36] 375186 0
Infant haematocrit level at first measurement after birth
Timepoint [36] 375186 0
first measurement after birth (varies depending on trial)
Secondary outcome [37] 375187 0
Peak haematocrit in the first 7 days after birth
Timepoint [37] 375187 0
first 7 days after birth
Secondary outcome [38] 375189 0
Patent ductus arteriosus requiring medical and surgical treatment (trialist defined)
Timepoint [38] 375189 0
neonatal period (varies depending on trial)

Eligibility
Key inclusion criteria
Studies will be included if they are randomised trials. Studies must compare at least two of the interventions of interest.

Participants will be women giving birth preterm (before 37 completed weeks’ gestation) and/or their babies. Women and babies will be included regardless of whether mode of delivery was vaginal or Caesarean, and whether the birth was singleton or multiple. Babies will be included regardless of whether or not they received immediate resuscitation at birth.
Minimum age
No limit
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
quasi-random studies will be excluded

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
We will conduct a systematic review of randomised trials with individual participant data pairwise and network meta-analysis, and a nested prospective meta-analysis.
Once the data from each of the trials are finalised, it will be combined into a common dataset, but a trial identifier code for each participant will be retained. New variables will be created from the combined dataset as required to address the hypotheses to be tested.
Analyses will include all randomised participants with available data, and the primary analyses will be based on intention-to-treat without imputation of missing data. Missing data will be described and reasons for missing data explored. The impact of missing data on conclusions about the comparative effects on the primary outcomes may be explored in sensitivity analyses if appropriate.

Subgroup analyses will be conducted for the primary outcome of death (prior to hospital discharge) and two key secondary outcomes (IVH any grade and any blood transfusion) if sufficient data are available. The subgroups that will be assessed are:
• Gestation at birth
• Type of pregnancy: singleton; multiple
• Mode of birth: caesarean before onset of labour; caesarean after onset of labour; vaginal
• Onset of labour (e.g. spontaneous onset or spontaneous prelabour ruptured membranes; not spontaneous onset or spontaneous prelabour ruptured membranes)
• Type of breathing onset (e.g. spontaneous breathing onset; supported lung aeration)
• Time of breathing onset relative to cord clamping (e.g. before cord clamping/milking; after cord clamping/milking)
• Sex
• Ethnicity
• Intrauterine growth restriction
• Suspected maternal antenatal/intrapartum sepsis
• Assessed as needing resuscitation and/or stabilisation
• Type of uterotonic drug (if any)
• Highest level of neonatal unit available at site
• Planned timing of uterotonic drug
• Planned position of the baby relative to the placenta whilst cord intact
• Need for immediate resuscitation at birth
• Type of consent waiver of consent (e.g. deferred consent; informed consent or assent; type of consent unclear)
• Study year

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
11000
Accrual to date
6590
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303904 0
Government body
Name [1] 303904 0
National Health and Medical Research Council
Country [1] 303904 0
Australia
Funding source category [2] 303909 0
Government body
Name [2] 303909 0
UK National Institute of Health Research
Country [2] 303909 0
United Kingdom
Primary sponsor type
University
Name
NHMRC Clinical Trials Centre, University of Sydney
Address
92-94 Parramatta Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 304052 0
None
Name [1] 304052 0
Address [1] 304052 0
Country [1] 304052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304410 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 304410 0
Ethics committee country [1] 304410 0
Australia
Date submitted for ethics approval [1] 304410 0
Approval date [1] 304410 0
29/11/2018
Ethics approval number [1] 304410 0
2018/886

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96854 0
Ms Anna Lene Seidler
Address 96854 0
NHMRC Clinical Trials Centre, University of Sydney
92-94 Parramatta Road, Camperdown NSW 2050
Country 96854 0
Australia
Phone 96854 0
+61 2 9562 5000
Fax 96854 0
Email 96854 0
lene.seidler@ctc.usyd.edu.au
Contact person for public queries
Name 96855 0
Anna Lene Seidler
Address 96855 0
NHMRC Clinical Trials Centre, University of Sydney
92-94 Parramatta Road, Camperdown NSW 2050
Country 96855 0
Australia
Phone 96855 0
+61 2 9562 5000
Fax 96855 0
Email 96855 0
icomp@ctc.usyd.edu.au
Contact person for scientific queries
Name 96856 0
Anna Lene Seidler
Address 96856 0
NHMRC Clinical Trials Centre, University of Sydney
92-94 Parramatta Road, Camperdown NSW 2050
Country 96856 0
Australia
Phone 96856 0
+61 2 9562 5000
Fax 96856 0
Email 96856 0
icomp@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No current plans to share IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9098Study protocolSeidler AL, Duley L, Katheria A, De Paco Matallana C, Dempsey E, Rabe H, Kattwinkel J, Mercer J, Josephsen J, Fairchild K, Andersson O, Hosono S, Sundaram V, Datta V, El-Naggar W, Tarnow-Mordi W, Debray TPA, Hooper S, Kluckow M, Polglase G, Davis P, Montgomery A, Hunter KE, Barba A, Simes J & Askie L on behalf of the iCOMP collaboration. Systematic review and network meta-analysis with individual participant data on Cord Management at Preterm Birth (iCOMP): study protocol. BMJ Open 2020;10:e034595. doi: 10.1136/bmjopen-2019-034595   378449-(Uploaded-28-08-2020-09-48-54)-Study-related document.pdf
9099Ethical approval    378449-(Uploaded-28-08-2020-09-51-36)-Study-related document.pdf



Results publications and other study-related documents

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

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSystematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-034595
N.B. These documents automatically identified may not have been verified by the study sponsor.