No "new or unusual causes of deaths" have been identified by an independent review into an unexplained increase in newborn babies dying in Scotland.
The report, published today, concludes that "various factors appear to have contributed to the increase, rather than one single identifiable cause".
A rise in babies being born prematurely, including a higher than expected number of twin and triplet births, appear to have contributed, but the "direct and indirect" impact of the Covid pandemic was less clear.
Previous studies have found that Covid infections during pregnancy were associated with a 35% increase in the incidence of premature births.
The vaccination status of the mothers was not recorded, but population-level analyses carried in Scotland and globally have repeatedly shown better pregnancy outcomes for women vaccinated against Covid.
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The report said the sample size - covering a total of 135 neonatal deaths in 2021/22 - was too small to reach "statistically valid" conclusions about any Covid links.
Compared to trends over the previous four years, it found that there had been a "significant increase" in neonatal mortality rates in Scotland during 2021/22 with an estimated 30 more infants dying before 28-weeks-old than would have been expected.
The investigation, commissioned by Healthcare Improvement Scotland on behalf of the Scottish Government, said it was not possible to say whether these deaths were "potentially preventable", but that the information available "did not find evidence of systemic failures of maternity or neonatal care, either across Scotland as a whole, or in any one NHS board" to explain this spike in deaths.
However, it noted that shortcomings in the data also meant that the review was unable to obtain detailed and accurate information in relation to healthcare staffing within maternity and neonatal services for the specific dates, wards and shifts when the babies' deaths occurred.
In addition, investigators found "significant variation in the quality of local review reports into neonatal deaths" submitted by health boards to Healthcare Improvement Scotland for the purposes of the review.
This was "likely to have resulted in missed opportunities for learning" and "limited the conclusions which could be reached".
A key recommendation is that that local perinatal mortality reviews and Significant Adverse Event Reviews (SAER) carried out by health boards going forward must be "carried out consistently and in a timely manner, and are of appropriate quality, with findings and actions set out clearly".
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As reported by the Herald, the alarm was first raised by public health experts after Scotland's neonatal mortality rate breached an upper warning threshold known as the 'control limit' in September 2021, following the deaths of 21 newborns.
It was the first time since monthly monitoring began in July 2017 that this had occurred.
The system is designed to detect any sudden changes or abnormalities in trends that are unlikely to be due to chance variation.
The September 2021 spike triggered an automatic investigation by Public Health Scotland, which proved inconclusive.
Concerns were raised again when the control limit was breached for a second time in March 2022 following the deaths of 18 infants within four weeks of birth.
In September 2022, the Scottish Government announced that an independent review would be carried out to examine all neonatal deaths between April 1 2021 and March 31 2022 "to find out if there is anything that may have contributed to the increase".
Healthcare Improvement Scotland (HIS) subsequently appointed Dr Helen Mactier - a retired consultant neonatologist and Glasgow University academic - to chair the expert panel leading the review.
The findings were initially expected in autumn 2022, but faced repeated delays.
Dr Mactier said: “The death of a baby is a devastating and traumatic experience for parents and families. Although increasingly small and sick babies now survive, there will be some babies for whom this is not the case.
"This does not necessarily reflect any shortcomings in care. However, it is important to acknowledge that some deaths may have been preventable.
"To prevent as many baby deaths as possible, review of both maternity and neonatal care is an essential part of midwifery, obstetric and neonatal practice.
“This review has helped to get a clearer understanding of the increase in neonatal deaths that occurred in 2021/22.
"We understand that there are still unanswered questions, and our recommendations are focused on ensuring that future opportunities to learn are not missed, and acted on in a timely and comprehensive manner.”
The investigation found that, during 2021/22, "more babies than expected were born before 28 weeks’ gestation" in Scotland.
Given that prematurity is associated with a higher risk of mortality, this "contributed to the overall increase in neonatal deaths in Scotland in 2021/22".
There was also a "significant increase" in the neonatal mortality rate for infants born at 32-36 weeks gestation, which investigators said should be a "focus in the implementation" of the review's recommendations.
Babies are considered full-term once a pregnancy reaches 37 weeks.
There was also a "higher than expected" number of multiple births - twins and triplets - which carry a higher risk.
The report also notes that data available for the UK as a whole points to a national increase in neonatal mortality during 2021 for babies born beyond 24 weeks' gestation.
It adds that while Scotland's neonatal mortality rate returned to normal levels in 2022/23 - meaning that they were in line with the average for 2015-2020 - provisional data for January to September 2023 "suggest a return to higher neonatal mortality rates" during the past year.
Jen Coates, director of bereavement support and volunteering at the stillbirth and neonatal deaths charity, Sands, said the publication of the report could be a "difficult time" for parents whose newborns died between April 2021 and March 2022.
She added: “We know that reports like this can also be worrying for anyone in Scotland who is pregnant now.
"We want all these families to know that Sands is here for them and for anyone in Scotland who has been affected by the death of a baby.”
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