Prematurity
in babies
Every
year, about one in eight babies, or 80,000 a year, are born prematurely (before
37 weeks) in the UK. Prematurity is the most common reason for babies to die in
the first month after birth. Premature babies who survive are more likely to
have short-term problems such as breathing and feeding difficulties and
infections. They may also have longer-term problems with functioning, behaviour
and learning. Whatever happens, having a premature baby is often a traumatic
and upsetting experience for women and their families.
Research,
like the ORACLE Trial and Children Study, to try to find the best ways to treat
premature labour and reduce short and long term problems is very important.
Results of the
original ORACLE Trial: women whose waters broke early
The
antibiotic erythromycin seemed to be helpful for babies in the short-term. In
the Erythromycin Group, babies were more likely to stay in the womb longer, and
were less likely to need help with breathing, to have infections, or to have an
abnormal brain scan.
The
other antibiotic, co-amoxiclav, also increased the time babies stayed in the womb
and reduced their need for oxygen. But the trial discovered an important
problem with co-amoxiclav. There was a small increase in the number of babies
born with a rare, sometimes very serious bowel condition called necrotising
enterocolitis (NEC) to women with broken waters who were in the Co-amoxiclav
Group. Because of its large size and design, the ORACLE trial was able to
identify this rare risk, even though co-amoxiclav had previously been routinely
used in pregnancy without reported problems.
Results of the
original ORACLE Trial: women who had signs of going into labour early but
didn’t have broken waters
The
antibiotics used in the trial (erythromycin and co-amoxiclav) did not have any
short-term effects (good or bad) for babies born to women with signs of early
labour without broken waters.
What was measured in the ORACLE Children study
The
questionnaire aimed to find out about children’s health, wellbeing and
educational attainment. These are areas where there may sometimes be problems
in any baby born early.
Functioning: The
questionnaire asked about the child’s vision, hearing, speech, walking,
dexterity (using their hands), emotions, pain, and aspects of thinking such as
learning and remembering. Children were classed by researchers as having a
‘functioning’ difficulty if parents reported that children had any difficulties
at all in any of these areas. As a result, ‘functioning’ difficulties can range
from the child having minor difficulties (things like wearing glasses,
requiring a hearing aid, not always being completely happy, or having some
difficulty when trying to solve day to day problems), to more severe problems
(such as being unable to walk, see, hear or speak, or having severe
difficulties with thinking and remembering).
Health problems and
behaviour:
The questionnaire asked about chest symptoms, hospital admissions,
fits/seizures, and specific medical conditions (including cerebral palsy), as
well as behaviour, emotions, hyperactivity, and relationships with others.
Results of the ORACLE
Children Study: women whose waters broke early
• For mothers whose waters broke early, having
antibiotics (erythromycin or co-amoxiclav) in the ORACLE trial did not make any
difference to their child’s functioning, behaviour, most medical conditions, or
Key Stage 1 results.
• Parents were specifically asked about bowel
problems because of the findings of the ORACLE trial (mentioned earlier). The
Children Study found that in the Co-amoxiclav Group, there was a small increase
in the number of children with bowel problems (2.7%) compared with those who
were not given co-amoxiclav at all (1.6%). However, the bowel problems in
children reported by these parents were mostly not serious (such as
constipation).
There
is, therefore, little evidence of long term effects (good or bad) for children
of women who had antibiotics when their waters broke early, but there is a need
for caution about use of co-amoxiclav in this situation.
Results of the ORACLE
Children Study: women who had signs of going into labour early without broken
waters.
• For mothers who had signs of early labour
without broken waters, having antibiotics (erythromycin or co-amoxiclav) did
not make any difference to their child’s behaviour, most medical conditions, or
Key Stage 1 results.
It was found that
cerebral palsy in children was somewhat more common when women with signs of
early labour did have antibiotics. In the Erythromycin Group, 3.3% of children
had cerebral palsy compared with 1.7% of children whose mothers who did not
have erythromycin. In the Co-amoxiclav Group, 3.2% of children had cerebral
palsy compared with 1.9% of children whose mothers who did not have any
co-amoxiclav
Looking at
it in more detail, the increase in the number of children with cerebral palsy
was clearest in the group of women who had both antibiotics (co-amoxiclav and
erythromycin together). In this group, 4.4% of children had cerebral palsy,
though even here the numbers with cerebral palsy remain quite small.
Summary
The ORACLE trial has shown that the babies of women who had PPROM and received erythromycin had an improved outcome compared to those who did not have PPROM, including increasing the time to delivery, reduction of infection and improved respiratory function. The ORACLE Children Study however revealed that these early improved outcomes do not make a substantial difference to the children’s health and development long-term.
However, in those women who did not have PPROM, the study suggested that there may be a small increased risk of functional impairment and cerebral palsy in the children of women who took antibiotics because of early premature labour.
These findings do not mean that antibiotics are unsafe for use in pregnancy. Pregnant women showing signs of infection should be treated promptly with antibiotics
Ref:
http://www.le.ac.uk/oraclechildren
http://www.rcog.org.uk/what-we-do/campaigning-and-opinions/statement/rcog-statement-oracle-children-study
http://www.rcog.org.uk/womens-health/clinical-guidance/preterm-prelabour-rupture-membranes-green-top-44
http://www.rcog.org.uk/womens-health/clinical-guidance/prevention-early-onset-neonatal-group-b-streptococcal-disease-green-
