Neonatal resuscitation after severe asphyxia--a critical evaluation of 177 Swedish cases.

Abstract

To evaluate neonatal resuscitation of infants born with severe asphyxia.
All case records of the 472 claims for financial compensation due to suspected medical malpractice in conjunction with childbirth in Sweden between 1990 and 2005 were scrutinized. Inclusion criteria were: gestational age > or =33 completed weeks, planned vaginal onset of delivery, a reactive CTG at onset of labour, neonatal asphyxia (defined as metabolic acidosis [pH of < 7.05 and/or a base excess of < -12]), or an Apgar score <7 at 5 min. It was assessed that 177 infants suffered from cerebral palsy or early death due to severe asphyxia presumably caused by malpractice around labour.
Median Apgar score at 5 min was 3, indicating that all infants needed immediate and extensive resuscitation. There was insufficient adherence to guidelines concerning neonatal resuscitation, including delayed initiation of excessive resuscitation in 19 infants, lack of satisfactory ventilation in 79 infants, and untimely interruption of resuscitation in 38 infants.
Compliance with guidelines for resuscitation of severely asphyctic newborn may be improved, especially concerning ventilation and prompt paging for skilled personnel in cases of imminent asphyxia. Documentation of neonatal resuscitation must be improved to enable reliable evaluation.

Full text

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Acta Pædiatrica ISSN 0803–5253
RESEARCH ARTICLE
Neonatal resuscitation after severe asphyxia – a critical evaluation of 177
Swedish cases
Sophie Berglund(Sophie.berglund@sodersjukhuset.se)1, Mikael Norman2, Charlotta Grunewald1, Hans Pettersson1, Sven Cnattingius3
1.Department of Clinical Science and Education S¨ odersjukhuset, Stockholm, Sweden
2.Department for Clinical Science, Intervention and Technology, Stockholm, Sweden
3.Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
Keywords
Asphyxia, Delivery, Malpractice, Resuscitation, CP
Correspondence
Dr Sophie Berglund, Department of Obstetrics
and Gynaecology, S¨ odersjukhuset,
S-118 83 Stockholm, Sweden.
Tel: +46 8 6161000 |
Fax: +4686163846 |
Email: Sophie.berglund@sodersjukhuset.se
Received
30 January 2008; revised 12 March 2008;
accepted 18 March 2008.
DOI:10.1111/j.1651-2227.2008.00803.x
Abstract
Aim: To evaluate neonatal resuscitation of infants born with severe asphyxia.
Method: All case records of the 472 claims for financial compensation due to suspected medical
malpractice in conjunction with childbirth in Sweden between 1990 and 2005 were scrutinized.
Inclusion criteria were: gestational age ≥33 completed weeks, planned vaginal onset of delivery, a
reactive CTG at onset of labour, neonatal asphyxia (defined as metabolic acidosis {pH of < 7.05
and/or a base excess of < –12}), or an Apgar score <7 at 5 min. It was assessed that 177 infants
suffered from cerebral palsy or early death due to severe asphyxia presumably caused by malpractice
around labour.
Results: Median Apgar score at 5 min was 3, indicating that all infants needed immediate and
extensive resuscitation. There was insufficient adherence to guidelines concerning neonatal
resuscitation, including delayed initiation of excessive resuscitation in 19 infants, lack of satisfactory
ventilation in 79 infants, and untimely interruption of resuscitation in 38 infants.
Conclusions: Compliance with guidelines for resuscitation of severely asphyctic newborn may be improved,
especially concerning ventilation and prompt paging for skilled personnel in cases of imminent asphyxia.
Documentation of neonatal resuscitation must be improved to enable reliable evaluation.
INTRODUCTION
Experience over the last century has demonstrated that peri-
natal mortality can be reduced by improved obstetrical and
neonatal care (1). With the aim to avoid errors in care by
implementing system-based changes, a systematic review of
the pitfalls and mistakes in the clinical practice of perinatal
medicine can be useful.
In a previous Swedish nationwide report, we identified
177 newborn infants over a 16-year period who had suf-
fered from severe birth asphyxia presumably due to delivery-
related malpractice. The most common causes of obstetrical
errors were that established guidelines for foetal surveillance
were not followed (i.e. negligence to supervise foetal well-
being), signs of foetal asphyxia were overlooked, misuse of
oxytocin, and a non-optimal choice of mode of delivery. We
concluded that foetal surveillance and attention to signs of
asphyxia must be improved, that there is a need to improve
cooperation between professionals in the labour unit and, to
create security barriers (2).
Less is known about potential flaws in the immediate
management of the asphyxiated newborn infant. Although
national guidelines for neonatal resuscitation have been in
place for many years (3), compliance with and the effective-
ness of these guidelines has not been studied. Video uptakes
from emergency rooms indicate that deviations from proto-
cols and errors in implementing guidelines are common (4).
The aim of this study was to scrutinize the initial resusci-
tation procedure of the previously identified 177 newborn
infants with severe asphyxia (2).
METHODS
We retrieved information on all 472 claims from 1990 to
2005 concerning suspected malpractice during pregnancy,
delivery and the neonatal period, sent to the County Coun-
cil’s Mutual Insurance Company under the Patients’ Advi-
sory Committee, Sweden (PAC, Person Skade Reglering AB
in Swedish). We included infants with a gestational age of
≥33 completed gestational weeks, planned vaginal delivery,
a normal CTG tracing at admission to the delivery unit, and
severe asphyxia-related neurological outcomes. We defined
labour-related asphyxia as an Apgar score of < 7 at 5 min
and, if the acid base status was measured in the umbilical
cord at delivery or shortly thereafter, metabolic acidosis as a
pH of < 7.05 and/or a base excess (BE) of < –12 (5,6). In all,
we included 177 infants with labour-related asphyxia, pre-
sumably caused by malpractice in connection with labour.
The selections of the cases and the investigation procedure
have previously been described in detail (2).
A structured protocol, including clinical data retrieved
from the obstetric and neonatal records, was used. We col-
lected information on pregnancy and maternity care, onset
of labour, presentation and mode of delivery, time of pag-
ing of a physician, the date and time of birth, gestational
age, gender, birth weight, Apgar scores at 1, 5 and 10 min,
714
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Berglund et al.
Neonatal resuscitation after obstetrical malpractice
Stimulation of the newborn
Improvement of status
Improvement of status
Give the infant to mother
Primary apnoea
Secondary apnoea Minutes Asystolia
•
Mask ventilation
Persistent bradycardia
•
Increase insufflations pressure
•
Increase inspiration time
•
Control of chest movements
Persistent bradycardia
•
Intubation
•
Ventilation
•
Adrenaline
Persistent bradycardia
•
Correction of acidosis
•
Repeat Adrenaline 1-2 times

0
•
•
•
•
•
•
•
•
•
Intubation
Ventilation
Chest compressions
Adrenaline 1-2 times
1
2
3
Persistent asystolia
Continue ventilation
Chest compressions
Repeat Adrenaline
5
•
•
•
Consider
cessation/discontinuation
of resuscitation
Correction of acidosis
Glucose
Persistent asystolia
51
Persistent apnoea
Consider
cessation/discontinuation of
resuscitation
30

>100
<100
Stimulation of the newborn
Figure 1 National Swedish guidelines for neonatal resuscitation 1996–2006.
umbilical cord acid base status, acts of resuscitation, the
length of stay (LOS) in the neonatal intensive care unit
(NICU), degree of hypoxic ischemic encephalopathy (HIE)
and investigations during the first weeks of age. We also re-
trieved information on the long-term follow-up, including
information on morbidity (cerebral palsy [CP] and other
neurological disorders), degree of disability or death from
the paediatric medical records.
All medical documents were scrutinized and computer-
izedbyoneofus(SB),aspecialistinobstetricsforaperiodof
15 years, a graduate of the American Neonatal Resuscitation
Provider Program, and also an instructor of team training in
neonatal resuscitation at the Centre for Education in Pae-
diatric Simulator (CEPS) at S¨ odersjukhuset in Stockholm
(1). The reviewer SB needed access to all information from
each case record and was therefore not blinded to the final
outcome.
National guidelines on neonatal resuscitation in place
during the period of the investigation are presented in
Figure1.(3)Accordingtotheseguidelines,(revisedin2006),
clearing the airways from meconium and initiating bag and
mask ventilation with initially 40% oxygen should be per-
formed immediately in all newborn infants with a heart
rate below 100 beats per min (bpm). In cases of asystolia,
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Berglund et al.
endo-tracheal intubation and administration of thoracic
compressions should immediately be performed. Early in-
tubation (within the first 2–3 min after birth) was rec-
ommended in cases with persistent bradycardia to ensure
free airways and satisfactory ventilation. Adrenalin, either
through the endo-tracheal tube or intravenously, should be
administered if the heart rate did not rise despite satisfac-
tory ventilation. Correction of metabolic acidosis should be
performed in cases of refractory bradycardia and terminal
apnoea (2 mmol buffer/kg i.v. for 5 min). Interruption of re-
suscitation should be considered if there is no evidence of
heart activity after 15 min or if no spontaneous breathing or
body movements have occurred during the first 30 min after
birth.
According to national clinical practice in obstetrics, the
paediatrician should be paged before the birth in cases of im-
minent asphyxia, in breech and instrumental deliveries, and
immediately when deliveries are complicated by shoulder
dystocia. In cases of unexpected asphyxia, the desirable time
for the arrival of skilled assistance was set at being within
4 min after birth for the paediatrician and within 15 min for
the neonatologist (back up).
Based on these guidelines, we established the following
cases of failure events in conjunction with neonatal resusci-
tation:
a) Artificial ventilation not started within 1 min after
birth in cases of apnoea and foetal heart rate <100
bpm.
b) Endotracheal intubation not performed within 3 min
after birth in cases of asystolia or in cases of persistent
apnoea and bradycardia.
c) Thoracic compressions not performed despite asysto-
lia.
d) Adrenaline not provided despite asystole or persistent
bradycardia.
e) Correction of metabolic acidosis not performed in
cases of asystole or persistent bradycardia.
f) Paediatrician or neonatologist not present before birth
despite knowledge of delivery complication.
g) Paediatricianorneonatologistnotarrivedwithin4min
after birth in cases of unexpected asphyxia.
h) Resuscitation not interrupted in spite of asystole for
>15 min or lack of spontaneous breathing or move-
ments > 30 min after birth.
All statistical analyses were performed in SPSS for Win-
dows, Rel. 14.0. 2005. Chicago, IL, USA: SPSS Inc. Data are
presented as median (range) values or as numbers and pro-
portions (%). The study was approved by the research ethics
committee at Karolinska Institutet (number 1589–2006).
RESULTS
All 177 mothers attended antenatal care on a regular ba-
sis. All cases had a reactive CTG recording at admission
for labour, indicating a non-asphyxiated foetus. The onset
of labour was spontaneous in 130 cases and induced in 47
cases.Insixofthe48spontaneouslydeliveredinfants,labour
was complicated by shoulder dystocia and nine infants were
born in breech presentation. Sixty-five infants were deliv-
ered by emergency caesarean section (CS), 62 by vacuum
extraction and 2 by forceps. Twelve of the 62 deliveries
by vacuum extraction were complicated by shoulder dys-
tocia. In twenty-five deliveries, trial of labour with vacuum
extraction or forceps was performed before converting to
emergency CS.
The median Apgar score was 5 (range 0–7) 10 min after
birth, and at an older post-natal age there was rarely any no-
tation of an Apgar score. A total number of 32 (18%) infants
died, 16 in the neonatal period and 16 during later follow-up.
Information about the time of the initiation of artificial
ventilation was noted in 167 of all 177 infants. Despite clear
indications, artificial ventilation was not initiated within
1 min after birth in seven infants (4.2%) while waiting for
a physician. Two of these had an Apgar score of ≤3 at
10 min and one infant died (Table 1). The median time for
mask ventilation was 8 min (range 0–30 min), and mask
ventilation proceeded for more than 15 min in 34 infants.
Eight of these infants had an Apgar score of ≤3 at 10 min
and seven infants died.
Endotracheal intubation was performed in 112 cases, and
the time of intubation was noted in 93 infants. Median time
forintubationwas6min(range0–180min).In72infants,in-
tubationwasnot,despiteclearindications,performedwithin
3 min after birth. Twenty-six of these infants had an Apgar
score of ≤3 at 10 min and 17 died (Table 1). Twenty-eight
infants were intubated after more than 10 min of age. The
time of the initiation of spontaneous breathing was noted for
119 infants of all 177 infants (67%), and the median time was
18 min (range 1–70 min). Forty-one infants were subjected
to chest compressions. Despite asystole at one min of age
(n = 33), thoracic compressions were not performed on five
infants, one of which had an Apgar score of ≤ 3 at 10 min
(Table 1).
Adrenaline was not provided in 14 of 33 infants with asys-
tolia at one min and nor was it provided in seven of 24
infants with persistent bradycardia. In all 21 infants where
adrenaline was not provided, six infants had an Apgar score
of ≤ 3 at 10 min and five of these infants died (Table 1). An
acid base status at birth or shortly after birth was analyzed
in 107 of all the infants (60%). The median pH at or shortly
after birth was 6,83 (Range 6,57–7,20) and BE –22,5 (–10 to
–40) mmol/L. One hundred thirty-five infants were treated
with buffer. The time for the correction of acidosis was noted
in 47 (35%) infants, and the median time for correction was
15 min (range 1–120 min). In two infants with asystolia or
persistent bradycardia there was no correction of metabolic
acidosis. Both had an Apgar score of ≤3 at 10 min and one
of these infants died (Table 1). Four infants had a post-natal
asphyxia after a traumatic delivery with a pH >7,05, a BE
>–12 mmol/L, but an Apgar score of < 7 at 5 min.
Information relating to the attending physician and
his/her time of arrival at the resuscitation was not routinely
noted. Of 92 vaginal-risk deliveries (65 instrumental, 18 with
shoulder dystocia and nine breech deliveries), the presence
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Berglund et al.
Neonatal resuscitation after obstetrical malpractice
Table 1 Failure events during neonatal resuscitation of 177 asphyxiated newborn infants and outcome
n (%)Apgar score 0–3
at 10 min (n)
Deaths1n(%)
1. Non satisfactory/unsatisfactory resuscitation
(a) Artificial ventilation not started within 1 min after birth
(b) Endotracheal intubation not performed within 3 min after birth
(c) Thoracic compressions not performed despite asystole2
2. Not satisfactory drug administration
(d) Adrenaline not provided despite asystole1
or persistent bradycardia3
(e) No correction of metabolic acidosis3despite asystole or persistent bradycardia
3. Late initiation of resuscitation
(f) Paediatrician, neonatologist or anaesthesiologist not present before the
birth in spite of known delivery complication
(g) Paediatrician, neonatologist or anaesthesiologist not arrived within 4 min
after birth in cases of unexpected asphyxia (n = 48)
4. Resuscitation not interrupted
(h) Resuscitation not interrupted:
o In spite of asystole for more than 15 min
o In spite of lack of spontaneous breathing during the first 30 min after birth
84
7
72
5
23
14
7
2
19
11
(47)
2
26
1
1
17
0
(14)
(24)
65(24)
21 (50)
23 (27)
844 (50)
38
8
30
8
15
7
8
(88)
(27)
1There were 16 neonatal deaths, and another 16 during follow-up (total deaths 32/177 = 18%).
233 neonates had asystole at 1 min of age.
324 neonates had persistent bradycardia at 5 min.
of a physician (paediatrician, neonatologist or anaesthesiol-
ogist) before birth was noted in 58 (63%) deliveries. Despite
knowledge of a delivery complication none of the physicians
were paged in advance in 11 cases, of which two infants had
an Apgar score of ≤ 3 at 10 min and three died (Table 1). In
cases of unexpected asphyxia (n = 48), the time of arrival
of the neonatologist, paediatrician or the anaesthesiologist
was noted in 42 cases. The time of arrival exceeded 4 min in
the case of eight infants, four of whom had an Apgar score
of ≤ 3 at 10 min and died later (Table 1).
Resuscitation was not interrupted in spite of asystolia for
more than 15 min in 8 infants, all of whom had an Apgar
score of ≤ 3 at 10 min and 7 eventually died. Similarly, resus-
citation was not interrupted in spite of lack of spontaneous
breathing or spontaneous body movements during the first
30 min after birth in 30 infants. Fifteen of these infants had
an Apgar score of ≤ 3 at 10 min, of which eight infants died
(27%, Table 1).
All infants were admitted to the NICU. Neonatal out-
comes following resuscitation are summarized in Table 2.
The median length of stay in the NICU was 24 days (range
1–120). Of 128 infants born at hospitals without facilities for
ventilator treatment, 48 (38%) were transferred to a univer-
sity hospital shortly after birth. Seventy-eight (44%) infants
were treated on ventilators for more than 24 h. Almost all
(94%) infants suffered from convulsions during the neonatal
period. EEG was performed on all infants and was patho-
logical in 80%.
Examination by cerebral CT scan was performed on 137
(77%) of all infants, and the scan was assessed as patho-
logical in 96 infants (70% of those scanned). In addition,
58 (33%) were examined with magnetic resonance imaging
(MRI) of the brain, and the MRI was abnormal in 49 infants.
Table 2 Neonatal outcomes and characteristics following severe asphyxia and
resuscitation
n (%)Length of stay or
duration, days
Range
NICU
Ventilator therapy >24 h
Convulsions
Anticonvulsive medication at
discharge
Transportation to university hospital
177
78
167
113
100
(44)
(94)
(64)
24
4
(1–120)
(1–19)
48(27)
DiagnosticsPathological
findings n
(%)
EEG
CT-Scan
Magnetic resonance tomography
Hypoxic ischemic encephalopathy (HIE)1
HIE I
HIE II
HIE III
177
137
58
(100)
(77)
(33)
142
96
49
(80)
(70)
(84)
10
69
58
(6)
(39)
(33)
1Information on HIE missing in 40 cases (23%).
The degree of HIE was diagnosed in 137 infants. Among
those, HIE I was diagnosed in 10, HIE II in 69 and HIE III
in 58 infants (Table 2).
MORTALITY AND LONG-TERM MORBIDITY
Information on mortality, neurological disorders, co-
morbidity and degree of impairment has been published
previously (2). Briefly, there were 16 neonatal deaths, and
another 16 infants died during the follow-up. Information
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Berglund et al.
on morbidity was for 45 infants based on case records with
a limited follow-up period. These infants were considered
to be suffering from an unspecified CP syndrome with di-
agnosed encephalopathy during the neonatal period. Nine
of these infants died before a final diagnosis could be made.
Sixty-nine of the 116 children with information about the
type of CP had dyskinetic CP, 18 spastic tetraplegia, 21 spas-
tic diplegia and 8 had hemiplegia.
DISCUSSION
We are very much aware of the difficulty of evaluating the
efforts of resuscitation in these most severely asphyxiated
infants since the final outcome was poor for all, but nev-
ertheless we could evaluate compliance with the guidelines
relating to neonatal resuscitation. In accordance with our
previous findings on insufficient adherence to current guide-
lines on foetal surveillance (2), we found indications of simi-
lar insufficiencies with respect to neonatal resuscitation and
that resuscitation was not performed according to guidelines
in the case of 84 infants (47%) (Table 1). Since ventilation
is the most important issue in cases of neonatal resuscita-
tion, we consider the most perturbing findings to be a de-
layedinitiationofextensiveresuscitation,lackofsatisfactory
ventilation by insurance of free airways by an early intuba-
tion, and untimely interruption of resuscitation (Fig. 1 and
Table 1).
Foetal surveillance at admission to the delivery ward reg-
istered no irregularities in any of the cases, presumably indi-
cating a healthy foetus. After delivery, umbilical cord blood
gas and acid-base assessment are the most objective deter-
minations of the foetal metabolic condition, but acid-base
status at birth or shortly thereafter was available only in 60%
of all cases. On the other hand, Apgar score at 5 min, which
is considered to be a reliable indicator of asphyxia in the ab-
sence of malformations, was noted in all cases (7). Median
pH at birth was 6, 83, median BE was –22,5 and the median
Apgar score at 5 min was 3, indicating that the neonates
in the study group suffered from profound asphyxia at birth
and were in great need of an immediate initiation of neona-
talresuscitation.Thedocumentationoftheresuscitationwas
generally poor and incomplete, which is a warning sign itself
that ought to be elucidated. Despite the difficulty of priori-
tizing documentation in these stressful situations, documen-
tation is necessary, not least in severe cases where infants
might have been injured by malpractice in conjunction with
labour. A simple and straight forward pre-printed protocol
simplifies documentation in cases of neonatal resuscitation
(8). The poor documentation also emphasizes that the re-
sults from our evaluation must be interpreted with caution.
Although there were several shortcomings during the
neonatal resuscitation, we consider it most likely that the
infants were primarily damaged by asphyxia in conjunction
with labour. Immediately after birth, the most important
shortcomings noted were, according to the national guide-
lines for neonatal resuscitation, unsatisfactory ventilation or
drug administration and a late initiation of or untimely in-
terruption of resuscitation.
Even if the majority of failure events defined in this study
is uncontroversial, failure to interrupt resuscitation after 15
or 30 min is more contestable. There could be clinical sit-
uations when the attending physician would have consid-
ered continuing resuscitation despite a longstanding asysto-
lia or persistent apnoea. For example, the parents may have
opposed discontinuation of resuscitation. Drugs adminis-
tered to the mother immediately before delivery may have
depressed spontaneous breathing in the newborn infant,
demanding continued artificial ventilation after birth. An
unclear diagnosis of intrapartum asphyxia—for other reasons
than depressant drugs—may also have added to a decision of
continued resuscitation beyond the stipulated points of no
return.
Although the value of routine correction of acidosis in
newborn infants has been rightfully questioned, we note that
in our study of severely asphyxiated infants, there were two
patients with asystolia or persistent bradycardia who did not
receive any correction of metabolic acidosis (9,10). Both had
an Apgar score of ≤3 at 10 min and one of these infants died.
An acid-base status was available in 107 out of 177 infants
and 135 infants were treated with buffer. The time for correc-
tion of acidosis was noted in only 47 (35%) infants. Among
these infants, correction of acidosis was in many cases de-
layed (median time for correction 15 min (range 1–120 min)
after birth). The point of time for correction of acidosis was
missing in too many cases to provide meaningful indication
whether an earlier correction could have improved the out-
come.
Post-asphyxial management at the neonatal intensive care
unit is also of vital importance for the chance of intact sur-
vival (11,12). Aggressive prevention and treatment of com-
plications such as recurrent acidosis and hypoxia, severe
hypoglycaemia, systemic hypotension, convulsions and
brain oedema are necessary (13,14). Recently, moderate hy-
pothermia has been reported as an evolving therapy with
promisingresultsincasesofneonatalasphyxia(13,15).Qual-
ity assurance of the post-asphyxial management remains to
be done.
Neuroimaging gives the possibility to time-relate a brain
injury. Clinical consequences are dependent on the topog-
raphy of the lesion. In cases of asphyxia during labour, basal
ganglia and thalamus lesions occur, predominantly because
of acute and severe perfusion failure in the term or near term
born infant. Newborn infants with pure basal ganglia and
thalamus lesions tend to have dyskinetic CP at follow-up,
often with severe motor problems but less pronounced cog-
nitive deficits. Infants with additional central and especially
hippocampal involvement are usually severely retarded in
both their motor and cognitive development and develop se-
vere bilateral spastic CP (16,17). The dominating types that
occurred among our cases were dyskinetic CP and spastic
tetraplegia, which are thought to be the most common sub-
types of CP that are associated with intrapartum hypoxic
events (14). Although some infants in the study-group may
have had encephalopathy prior to labour, we find it proba-
ble that suboptimal care around delivery aggravated the en-
cephalopathy in these infants. The median LOS at NICU
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