Necrotising enterocolitis and late onset sepsis are devastating complications of preterm birth. The pathology of neither is fully understood, but is associated with immaturity of the protective functions of the gut. One aspect of this relates to the millions of helpful bacteria that normally live in the gut and whose presence is essential for our well-being. We know that babies born prematurely do not usually acquire a normal diverse population of helpful bacteria in their gut; it has been hoped that giving them helpful bacteria (probiotics) like those found in healthy full term babies will strengthen the gut defences and provide protection.
We chose to examine whether the probiotic Bifidobacterium breve strain BBG-001 protects babies from necrotising enterocolitis, sepsis and death; the full protocol describing the trial in detail is available at www.npeu.ox.ac.uk/pips/protocol. Half of the babies in the trial were allocated to receive the probiotic and half to receive an identical inactive placebo product. When the PiPS trial was planned, there had been no reports of probiotics helping in this regard. However, as the trial progressed there were a number of publications all using different probiotics. The results have been combined and strongly suggest that probiotics might reduce both necrotising enterocolitis and death. We monitored these publications and were concerned not only about the quality of some of them but also questioned whether it is acceptable to combine trials using different probiotics when the scientific data suggest that different probiotics have different effects. Despite advice from some neonatologists that probiotics should be used routinely, the PiPS Trial Steering Committee advised that recruitment should continue and we reached our target in July 2013 with 1,315 babies born between 23 and 30 weeks’ gestational age taking part in the trial.
In total, 1,310 babies completed the trial making this the biggest study so far of probiotics in preterm babies and big enough for us to be very confident about the results (we were unable to use the results from only five babies). Furthermore we believe that the population of babies in the trial is typical of the babies in our neonatal units.
As with other trials we did not find any complications associated with giving probiotics, but neither did we find any evidence that the probiotic that we gave protected the babies from necrotising enterocolitis, sepsis or death.
This result does not support the routine use of this probiotic and, we believe, challenges the validity of combining the results of trials using different probiotics.
We are very grateful to all of the staff who made this trial possible, to the Yakult Honsha Co Ltd. Tokyo who provided the interventions, but were not involved in any other aspect of the trial, and above all to the families who gave permission for their babies to take part.
The study was funded by the UK National Institute for Health Research Health Technology Assessment programme.
Stillbirth affects around 1 in 200 pregnancies in high-income countries and is a devastating and traumatic event for women and their families. Guidance on contact between parents and their stillborn baby has changed over time and has been based on mixed evidence.
NPEU researchers Julie Hennegan, Jane Henderson and Maggie Redshaw have published a systematic review of the published evidence on the impact of contact with the stillborn baby on parental mental health, well-being and satisfaction. Their review found conflicting and sparse evidence on the impact of holding the stillborn baby on mothers’ mental health and well-being, both in the short and longer term. The studies reviewed consistently found that mothers valued contact with their stillborn baby and were satisfied with their decision to have this contact.
Led by the MBRRACE-UK team at the University of Leicester, this report details the findings from review of 130 term stillbirths, of which 85 were examined in detail by a panel of clinicians including midwives, obstetricians and pathologists.
The enquiry found that half of all term, singleton, normally-formed, antepartum stillbirths had at least one element of care that required improvement which may have made a difference to the outcome. Opportunities missed in two thirds of cases included: correctly identifying women with risk factors for diabetes and offering them testing; and appropriate screening and monitoring the growth of the baby. Almost half of the women had contacted their maternity units with concerns that their baby’s movements had slowed, changed or stopped. In half of these cases there were missed opportunities to potentially save the baby including a lack of investigation, misinterpretation of the baby’s heart trace or a failure to respond appropriately to other factors. Internal hospital reviews were only documented for a quarter of the deaths and their quality was highly variable. A post-mortem was carried out in only half of the cases, but most were of satisfactory or good quality. A generally good standard of bereavement care was provided for parents immediately following birth, including the offer of the opportunity to create memories of their baby. Read the full report for the detailed findings and the key actions for improving services to help prevent the terrible heartache experienced by three families every day across the UK. Follow us on Twitter @TIMMSleicester@mbrrace
Are you a researcher looking to get back into work after a career break for family, health or caring reasons? If you've been away from the world of work for at least two years, hold a science or related degree, and a doctorate or at least three years research experience you may be eligible for a Daphne Jackson Fellowship. Applications are now open for three University of Oxford sponsored Daphne Jackson Fellowships - for more information see the University's vacancy pages. To talk about potential opportunities for pursuing a Daphne Jackson Fellowship with us at the NPEU please contact Maria Quigley for an informal discussion.
New research on models of peer support during pregnancy and the postnatal year has been published in BMC Pregnancy and Childbirth. This qualitative study, by NPEU's Jenny McLeish and Maggie Redshaw, is based on interviews with 89 participants and focuses on the perceptions of the trained volunteers who give peer support and the mainly disadvantaged mothers who receive it, exploring their understanding of what peer support is, who a peer supporter is, and the unique nature of the peer support relationship. Read the full paper.
SIFT, a trial of the speed of increasing milk feeds in very preterm or low birthweight babies, finished recruitment a year early in June and has started its 2 year follow-up. In total 2804 participants were recruited at 58 sites across the UK and Ireland. Achieving the recruitment target a year ahead of schedule is a testament to the hard work and dedication of all the recruiting sites - thank you!