NeoCLEAR
Research type
Research Study
Full title
NeoCLEAR: Neonatal Champagne Lumbar punctures Every time – An RCT. A multicentre, randomised controlled 2x2 factorial trial to investigate techniques to increase lumbar puncture success
IRAS ID
223737
Contact name
Charles Roehr
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN14040914
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
Every year at least 15,000 newborns undergo a lumbar puncture to confirm suspected meningitis. Lumbar puncture technique varies in practice, and success rates are low (50-60%) meaning procedures need to be repeated, causing distress to the infants and their parents and extending treatment and hospital stay time. There is a pressing need for a large randomised controlled trial to determine which lumbar puncture technique is the best approach.We have designed a pragmatic (i.e a low level of trial-driven standards is enforced and sites work to their standard practices and processes for generalisability of the trial results), multi-centre, randomised controlled trial comparing two traditional lumbar puncture techniques:
1. the infant in sitting position versus lying position; and
2. early versus late stylet removal.The participants will be randomly allocated (with equal chance i.e. 1:1:1:1) to one of the following technique combinations:
- Lying position and early stylet removal
- Sitting position and early stylet removal
- Lying position and late stylet removal
- Sitting position and late stylet removalWe aim to determine the optimal technique for performing lumbar puncture in infants. The results of this trial will inform best practice, and ultimately, improved technique would result in:
- Fewer uninterpretable samples
- Fewer repeated procedures
- Reduced distress for infants & families
- Decreased antibiotic use and risk of antibiotic resistance
- Reduced NHS costs due to fewer procedures, reduced length of stay, shorter antibiotic courses, and minimised antibiotic-associated complications.Summary of Results
: Newborn babies are more susceptible to getting meningitis, and this can be fatal or have lifelong complications. A lumbar puncture is an essential test for diagnosing meningitis. Lumbar puncture involves taking a small amount of spinal fluid from the lower back using a needle. Analysing the fluid confirms or excludes meningitis, allowing the right treatment to be given. Lumbar punctures are commonly performed in newborns, but are technically difficult. In 50–60% of lumbar punctures in newborns, either no fluid is obtained or the sample is mixed with blood, making analysis less reliable. No-one knows which is the best technique and so practice varies. The baby can be held lying on their side or sat up and the ‘stylet’, which is a thin piece of metal that sits inside (and aids insertion of) the needle, can be removed either soon after passing through the skin (i.e. ‘early stylet removal’) or once the tip is thought to have reached the spinal fluid (i.e. ‘late stylet removal’).We wanted to find the best technique for lumbar puncture in newborns. Therefore, we compared sitting with lying position, and ‘early’ with ‘late’ stylet removal.
We carried out a large trial in newborn care and maternity wards in 21 UK hospitals. With parental consent, we recruited 1,082 full-term and premature babies who needed a lumbar puncture. Our results demonstrated that the sitting position was more successful than lying position, but the timing of stylet removal did not affect success.
In summary, the sitting position is an inexpensive, safe, well-tolerated and easily learned way to improve lumbar puncture success rates in newborns. Our results strongly support using this technique in newborn babies worldwide
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0222
Date of REC Opinion
12 Jun 2018
REC opinion
Further Information Favourable Opinion