Feasibility of Resuscitation (Apnoeic Babies) before Cord Clamping

Lindsay MildenhallANZCOR

Plan

• Physiology of the transition

• ?Benefit of breathing with delayed cord clamping

• Equipment (no commercial interest!)

• Trials assessing feasibility of assisting breathing before cord clamping: ?Results

• Parents / Medical Staffs views

• Ongoing Trials

• Video

The Physiology• Fetus LV preload

• Placental blood delivered via UV →DV → FO → LV

• Fetal P Vein (preload) return to LV negligible

(Can increase somewhat with in utero fetal breathing movements)

• Early Cord Clamping:

1. Low resistance placental circuit• (LV exposed to ↑afterload)

2. 30-50% of venous return cut off → period of flow fluctuations

• ?bad for you…..Preterm baby and IVH

• May explain newborn initial low HR on HR normograms

Dilemmas remain

• DCC seems beneficial*; + breathing may add benefit

• Majority DCC trials exclude pre term babies that needed resus

• Apnoeic infants: ICC → Removed to Resuscitaire

• Unsure of best CC strategy during CS delivery• 70% premature babies delivered by CS (US 2008)

* Fogarty M et al, Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 .

Evidence Suggesting Advantage of

Breathing before CC

AnimalsHumans

Experimental Evidence for Advantage of DCC + Breathing (Animals)

• CVS changes in Preterm lamb model 26-28 w; • 2 groups:

-●- UCC 2min before vent commenced -○- Vent commenced. UCC av ∼4min PBF

Bhatt S et al J Physiol. 2013 Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs.

An aside: HR Normograms

• HR graphs

Blank et al (RWH) Aust

Humans: Observational Studies: Breathing before CC

Ersdal et.al. 2014

Term and pretermn > 15 000

CC before onset of breathing

• More likely to die

• The longer delay from SR onset to CC,

the better outcome

• Beyond 2 mins DCC risk minimised

Nevill, Meyer 2015

Preterm infants < 30 weeks

Breathing DCC vs Non breathing DCC:

• Less intubation

• Reduced CLD

• Reduced severe IVH

• Increased day 1 Haemoglobin

• Death rate similar

Breathing before Cord Clamping seems advantageous

1. Is it feasible to assist breathing during the transition with the cord unclamped?

2. Does it provide clinical benefit to the baby?

Questions to be Answered

The Equipment needs to provide respiratory support

1. Does not restrict providing full standard of care

2. Able to monitor the infant

3. Prevent kinking / stretching of cords

4. Unhindered care to the mother

5. Acceptable to all parties

T piece DeviceHeated gel platform Respiratory

function module:HR, Sat’s FiO2, TV

Concord

Lifestart

Feasibility Studies using these

and other devices during DCC

RCTs: LIFESTART

Katheria et.al. 2016

23 – 31w

n = 150

CS (85%) / NVD delivered to LIFESTART

• All 60 seconds DCC

• V-DCC: If Apnoeic → CPAP +/- PPV

• DCC: If Apnoeic → stimulation

• Only 13 didn’t breathe before DCC!

• 78% to LIFESTART for resus (Obs nervous)

Katheria et.al. 2017

Term (at Risk)

Vaginal deliveries only

n = 60

• 5 min DCC (Apnoeic to LIFESTART)

• 1 min DCC (If apnoea immediate clamp)

• 13/30 5 min DCC to Lifestart

• 8/13 just stimulation +/- Ox, 2 PPV, 1 intubate

• 5 mins DCC achieved in all 30

CONCORD and others

Brouwer E et al 2016

Holland

26 - 35w

n = 37

ObservationalFeasibility

CONCORD

• Baby stabilised(+/- PPV) then Cord ClampingStable = HR >100, TV ≥ 4mls /kg on CPAP, Sat’s > 25% FiO2 < 0.4

• Cord clamp time: median 4min 23 secs• Temp 36.0

• Learning curve: 89% successful (33/37)

• No post clamping bradycardia at any gestation

Duley L et al2018

UK

28-29w

n = 276 babies

Multicentred RCT

• DCC at 2 minutes + resus if needed• Cord clamped within 20secs + resus if needed

DCC Group:• 50-70 % of respiratory support beside mother

including 50% intubations• Median DCC 120 secs

Medical Staff / Patients Satisfaction UK• Parents: Generally positive

• By watching resus, reassured staff doing best they could

• Having baby close less distressing than taken away

• Clinicians: Generally positive

• Improved parental communication

• Less experienced staff insecure about being watched

• Sterility in theatre an issue

Yoxall CW et al Providing immediate neonatal care and resuscitation at birth beside the mother: clinicians' views, a qualitative study. BMJ Open. 2015

Medical Staff / Patients Satisfaction USAVaginal delivery only

• Parents: Generally positive

• Good to see and make contact with baby in first minutes

• Positive impression of resus by bedside and of radiant warmer

• Clinicians: Generally negative

• 50% concerns regarding suboptimal access to baby

• Uncomfortable with interventions by bedside

Katheria AC et al Acceptability of Bedside Resuscitation With Intact Umbilical Cord to Clinicians and Patients' Families in the United States. Front Pediatr. 2018

Prem Vent First: Pilot Study Feasibility / Safety (USA)

• Instructional video • Simulations• Coordinator at each

delivery

• Problems Identified:

• ECG leads not sterile

• Crowding.

Winter Jet al. Ventilation of Preterm Infants during Delayed Cord Clamping (VentFirst): A Pilot Study of Feasibility and Safety. Am J Perinatol. 2017

CS

X

X

Vaginal

Hard with Short cord

Summary

• Is it feasible?

•Yes!

• Is there a clinical benefit?

•On-going research topic

2 Ongoing studies

ABC Study ACTRN126150010226516

01VentFirstNCT0274245

02

Primary Outcome: RBC tx rates (Echo data)NDT @ 2 years for ≤ 29wWraps and Sterile CPAP circuits

Single Centre RCT – Intervention with those performing outcome assessment masked

n = 120 < 31 w NVD and CS

If no regular breathing at 15 secs randomised

Control: DCC: 50 secs + wrap / position / stimulate

Intervention: DCC: 50 secs + resp support (CPAP/PPV)

Primary Outcome: Incidence of IVH at 7-10 day Head USS

Multicentre RCT – Intervention with those performing outcome assessment masked

n = 940 23 – 28.6 w NVD and CS

Control: DCC: For 30 seconds if not breathing;

60 seconds if breathing

Intervention: DCC: For 120 seconds:

Assessed at 30 seconds. If neededCPAP or PPV given for 90 secs

Chest Compressions with Intact Cord

• If the resuscitation extends to chest compressions

does it make physiological sense to leave the cord

unclamped?

ABC Study: ‘ Assisted Breathing before Cord Clamping’