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Trial registered on ANZCTR


Registration number
ACTRN12615001026516
Ethics application status
Approved
Date submitted
8/09/2015
Date registered
1/10/2015
Date last updated
15/09/2021
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Provision of breathing support during delayed cord clamping in preterm infants.
Scientific title
In preterm infants <31 weeks receiving delayed cord clamping (DCC) at birth but who do not concurrently establish spontaneous ventilation, does breathing support during DCC versus no breathing support during DCC effect the volume of placental transfusion and cardiovascular stabilisation.
Secondary ID [1] 287387 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The ABC Study: 'Assisted breathing before cord clamping"
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraventricular haemorrage 296084 0
Prematurity 296082 0
Anemia requiring red blood cell transfusion 296083 0
Condition category
Condition code
Cardiovascular 296480 296480 0 0
Normal development and function of the cardiovascular system
Reproductive Health and Childbirth 296344 296344 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to standard treatment, breathing support in the form of positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) delivered by mask and pressure controlled device. Infants will be randomised at 15 sec of age once their breathing has been assessed. Breathing support will begin at 20sec of age, will be continued for a duration of 30sec; the intervention will take place while 50 sec DCC is occuring (cord clamping to take place at 50sec of age). ILCOR and NZ resuscitation guidelines will be adhered to (initial positive pressure will be 20-25 cm water and CPAP 5-8cm water).
The intervention received will be recorded on a data capture sheet including PPV time period in seconds received and or CPAP time period in seconds.
Intervention code [1] 292739 0
Prevention
Intervention code [2] 292899 0
Treatment: Other
Comparator / control treatment
Standard treatment consists of: position (placed on back, head placed in neutral position) and thermal wrap during 50 sec delayed cord clamping
Control group
Active

Outcomes
Primary outcome [1] 295995 0
Red blood transfusion rates
Assessed by reviewing hospital records of red blood cell transfusions received, number received, age of first transfusion in days. The study centre's red cell transfusion guideline will remain unchanged during the study and guideline adherance will be monitored. Infants transferred to other hospitals for surgery or ongoing care will be excluded from primary outcome analysis as so to avoid differing red cell transfusion guidelines.
Timepoint [1] 295995 0
From birth to time of discharge from neonatal admission
Secondary outcome [1] 317527 0
Length of hospital stay in days as recorded in hospital records
Timepoint [1] 317527 0
Birth to discharge from neonatal admission
Secondary outcome [2] 317124 0
Transitional circulation assessed by echocardiogram within first 24 hours of age, data collected from hospital records.
Timepoint [2] 317124 0
One echocardiogram assessment will be done at (6 to 12 hours of age if possibe) < 24hours of age. Inotropic support (type, dose and length of treatment in hours) during the first 24hours after birth.
Secondary outcome [3] 317125 0
Phototherapy received as recorded in hospital records and entered on designed data capture sheet
Timepoint [3] 317125 0
First week of life
Secondary outcome [4] 317525 0
Late onset sepsis (LOS) defined by positive blood culture or CSF after 48hours as recorded in hospital records
Timepoint [4] 317525 0
From 48hours of age to discharge from neonatal admission
Secondary outcome [5] 317526 0
Death as recorded in hospital records
Timepoint [5] 317526 0
Birth to discharge from neonatal admission
Secondary outcome [6] 317123 0
Temperature after the procedure measured by digital underarm thermometer and recorded on designed data capture sheet
Timepoint [6] 317123 0
At 5min of age
Secondary outcome [7] 317127 0
Chronic lung diease defined as respiratory support or oxygen at 36 week corrected gestational age as documented in hospital records and designed data capture sheets
Timepoint [7] 317127 0
At 36 week corrected gestational age
Secondary outcome [8] 317129 0
Neurodevelopmental outcome as assessed at 2 year of age (Bayley III score) at Neonatal Clinic (current standard practice for infants born equal or <29 weeks
Timepoint [8] 317129 0
2 years of age
Secondary outcome [9] 317524 0
Retinopathy of prematurity (ROP), requiring laser therapy as recorded in hospital records
Timepoint [9] 317524 0
Birth to discharge from neonatal admission
Secondary outcome [10] 317122 0
Endotracheal intubation (ETT) and surfactant received.
Type and dose received will be recorded on designed data capture sheets at the bedside and verified from hospital records
Timepoint [10] 317122 0
First 24hours of life
Secondary outcome [11] 317126 0
Length and type of ventilation support as documented in hospital records and entered on designed data capture sheet
Timepoint [11] 317126 0
From birth to time of discharge from neonatal admission
Secondary outcome [12] 317128 0
Intraventricular haemorrage grades 3 & 4 as reported in hospital records and defined by ANZNN coding criteria
Timepoint [12] 317128 0
Day 5 and day 28
Secondary outcome [13] 317130 0
Necrotising enterocolitis (NEC), defined by modified Bells stage 2 or higher as reported in hospital records
Timepoint [13] 317130 0
Birth to discharge from neonatal admission

Eligibility
Key inclusion criteria
Infants born <31 week gestation and undergoing delayed cord clamping (DCC); born by vaginal or caeserean section and deemed not to have regular rhythmic breathing (chest wall movement) after 15sec of DCC.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants born equal or > 31 week gestation, known congenital abnormality, twin-to-twin transfusion syndrome, severe antenatal intrauterine growth restriction (estimated fetal weight <10th customised centile), placental abruption, delivery of placenta and infant simultaneously (en caul), short umbilical cord, obsterician refusal, declined antenatal consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents will be given a written information sheet about the study by a study member before labour where possible. In cases where active labour is in progress and consent before birth is not possible, deferred consent for study entry is proposed. Eligible infants that receive DCC will be randomised at 15 sec of age once the breathing has been assessed.
Study groups and management: A standard treatment arm will be compared to an intervention arm. Standard treatment consists of: position (placed on their back, head in neutral position), and thermal wrap during 50sec delayed cord clamping.
Interventional treatment: In addition to the standard treatment above, breathing support in the form of intermittent positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) delivered by mask and pressure controlled device.
Randomisation: Randomisation will occur via sequentially numbered opaque sealed envelopes. A card folded within the envelope will state whether the infant is to receive standard treatment (no breathing support) or breathing support (intervention) during delayed cord clamping. After delivery these cards will be attached to the data collection sheet. The infants study number will be documented in the clinical notes. Groups will be stratified into 24-25, equal/> 26-27, equal/>28 -29 and equal/>29 week gestation.
Blinding: The attending resuscitation team will not disclose to clinicians whether infants received respiratory support during DCC or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be carried out on an intention to treat basis. IBM statistics for data analysis version 22.0 will be used. Non-parametric data will be analysed using Mann-Whitney U while categorical variables will be compared using Pearson Chi-Square. Infants enrolled in the study will be stratified into groups [<26, equal/>26-27.6, equal/ >28 -30.6].

Our observational data indicated that 60% of infants that received DCC and did not breathe received a RBC transfusion. Aiming for a 50% reduction in RBC transfusion, would require 100 infants whose primary outcome can be assessed. This would give the study 80% power at a significance level of 0.05. For a secondary composite outcome of death, CLD or severe IVH, the sample size would allow a 36% difference in outcome to be detected (80% power, significance 0.05). We plan to randomise 60 infants to each group. Based on mortality of 15% this will allow for the loss of 10 infants per group and result in 50 infants per group whose primary outcome can be determined. Our average admission rate is 70 <31 week infants per year, and, estimating that 50% of infants do not breathe regularly by 15secs of age, the length of this study will be approximately 3 years.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2015
Actual
17/03/2016
Date of last participant enrolment
Anticipated
31/07/2020
Actual
15/09/2020
Date of last data collection
Anticipated
Actual
1/02/2021
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 7131 0
New Zealand
State/province [1] 7131 0
Auckland

Funding & Sponsors
Funding source category [1] 291953 0
Hospital
Name [1] 291953 0
Ko Awatea Project Fund (called Tupu fund): awarded by Counties Manukau Health, Middlemore Hospital, Research Office
Country [1] 291953 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
Middlemore Hospital
Hospital Rd
Otahuhu, Auckland
New Zealand 1640
Country
New Zealand
Secondary sponsor category [1] 290624 0
None
Name [1] 290624 0
Address [1] 290624 0
Country [1] 290624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293453 0
Northern A District Health and Disability Ethics Committee
Ethics committee address [1] 293453 0
Ethics committee country [1] 293453 0
New Zealand
Date submitted for ethics approval [1] 293453 0
14/09/2015
Approval date [1] 293453 0
22/12/2015
Ethics approval number [1] 293453 0
15/NTA/146

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

Contacts
Principal investigator
Name 59970 0
Mrs Elizabeth Nevill
Address 59970 0
Neonatal Care
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 59970 0
New Zealand
Phone 59970 0
+64 9 2760044 EXT 8365 / +64 21300877
Fax 59970 0
+64 9 2760091
Email 59970 0
elizabeth.nevill@cmdhb.org.nz
Contact person for public queries
Name 59971 0
Elizabeth Nevill
Address 59971 0
Neonatal Care
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 59971 0
New Zealand
Phone 59971 0
+64 9 2760044 EXT 8365 /+64 21300877
Fax 59971 0
+64 9 2760091
Email 59971 0
elizabeth.nevill@cmdhb.org.nz
Contact person for scientific queries
Name 59972 0
Elizabeth Nevill
Address 59972 0
Neonatal Care
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 59972 0
New Zealand
Phone 59972 0
+64 9 2760044 EXT 8365 / +64 21300877
Fax 59972 0
+64 9 2760091
Email 59972 0
elizabeth.nevill@cmdhb.org.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethic approval do not allow sharing of data.


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
SourceTitleYear of PublicationDOI
EmbaseAdaptation for life after birth: a review of neonatal physiology.2017https://dx.doi.org/10.1016/j.mpaic.2016.11.008
EmbaseThe assisted breathing before cord clamping (ABC) study protocol.2021https://dx.doi.org/10.3390/children8050336
EmbaseEffect of Breathing Support in Very Preterm Infants Not Breathing During Deferred Cord Clamping: A Randomized Controlled Trial (The ABC Study).2023https://dx.doi.org/10.1016/j.jpeds.2022.09.025
N.B. These documents automatically identified may not have been verified by the study sponsor.