TRUFFLE study

Question 1

Truffle Study - full name, author, year, journal

Answer 1

Trial of Umbilical and Fetal Flow in Europe: “2 year neurodevelopmental and intermediate perinatal outcomes in infants with very preterm fetal growth restriction (TRUFFLE): a randomised trial”

Author: Lees CC, et al.
Year: 2015
Journal: Lancet

Question 2

TRUFFLE - clinical question:

Answer 2

In severe early-onset FGR between 26 and 32 weeks, what is the best monitoring strategy to time delivery so as to optimise 2-year neurodevelopmental outcome while minimising fetal/neonatal death

Question 3

Why did the TRUFFLE trial matter?

Answer 3

• Before TRUFFLE, clinicians knew that umbilical artery doppler, ductus venosus doppler and CTG were useful in severe early FGR, but there was uncertainty about which parameter should actually trigger delivery
• TRUFFLE specifically addressed timing of birth in very preterm FGR

Question 4

TRUFFLE study design:

Answer 4

• Multicentre randomised trial
• Women w early-onset FGR, defined by:
  > 26+0 to 31+6 weeks
  > AC <10th centile
  > Umbilical artery PI >95th centile
• Randomised into 1 of 3 delivery-monitoring strategies:
  1. CTG short term variation only
  2. Early DV change as trigger
  3. Late DV change as trigger

*All groups also had “safety-net” criteria mandating delivery regardless of randomisation, such as very abnormal FHR patters or severe Doppler deterioration

Question 5

TRUFFLE - primary outcome

Answer 5

Primary outcome: survival without neurodevelopmental impairment at 2 years, defined using:
> Absence of cerebral palsy
> No severe neurosensory impairment
> No Bayley III score <85

Question 6

TRUFFLE - main findings:

Answer 6

Among 503 randomised women:
> Median gestation at delivery was 30.7 weeks
> Mean birthweight was 1019g

Proportion surviving without neuroimpairment at 2 years was:
> 77% in the cCTG STV group
> 84% in the early DV group
> 85% in the late DV group

*The primary comparison across all 3 groups was not statistically significant (p = 0.09). However, among survivors, outcomes were best in the late DV group, and the investigators concluded that timing delivery using late DV changes together w cCTG might improve 2-yr developmental outcome

Question 7

TRUFFLE - perinatal outcome

Answer 7

Overall outcomes were better than many expected for such severe early FGR:
- 92% survival
- Cerebral palsy only in about 1% of those with known outcome

-> reassured that with intensive surveillance and protocolised delivery, outcomes in severe early FGR can be better than historic series

Question 8

What did TRUFFLE change in practice?

Answer 8

• In early-onset severe FGR, use cCTG plus ductus venosus doppler for surveillance and delivery timing
• DV changes are particularly useful in preterm FGR
• Delivery should not be based on cerebral Doppler changes alone
• “safety-net” criteria remain crucial

Question 9

TRUFFLE one liner summary:

Answer 9

TRUFFLE showed that in severe early-onset FGR between 26 and 32 weeks, timing delivery using computerized CTG with ductus venosus Doppler—particularly waiting for later DV changes within a strict safety-net protocol—was associated with the best 2-year neurodevelopmental outcomes among survivors, and that delivery should not be based on cerebral Doppler changes alone.