Dr KK Aggarwal
Rajasthan state
consumer forum on Friday imposed a fine of Rs 48 lakh on a private
hospital situated at Kothputli town on the outskirts of Jaipur, for its
negligence that led to an infant turning blind.
Case
Nikita was admitted to
Sanjivani Hospital situated at Kothputli on August 30, 2014, when she was told
that the infant was underweight.
She was given 30%
oxygen.
The infant developed ROP
(retinopathy of prematurity)
Allegation: 30% oxygen was too much and caused ROP
Normal O2 should be 21%
Award: 45 lakh compensation
Discussion
Is it negligence, error
of judgment or difference of opinion?
What is ROP?
· ROP is a
developmental vascular proliferative disorder that occurs in the retina of
preterm infants with incomplete retinal vascularization.
· It is an
important cause of severe visual impairment in childhood.
· ROP
develops in 21% of patients and severe ROP in 5% in infants < 32
weeks gestation. No infant born at >28 weeks GA required surgical
intervention.
· The incidence
of ROP in preterm infants (BW <1251 g) is 68%.
· The incidence
of ROP is 8%, 19% and 43% among infants born at ≥32 weeks, >27 to
31 weeks, and ≤27 weeks gestation, respectively
Risk factors
The most important risk
factor for developing ROP is prematurity. However, more than 50 separate risk
factors have been identified.
· Low birth
weight, low gestational age, assisted ventilation for longer than one week,
surfactant therapy, high blood transfusion volume, cumulative illness severity,
low caloric intake, hyperglycemia, and insulin therapy, have been independently
associated with higher rates of ROP
· Other possible
risk factors include sepsis, fluctuations in blood gas measurements,
intraventricular hemorrhage, bronchopulmonary dysplasia, systemic fungal
infection, and early administration of erythropoietin for the treatment of
anemia of prematurity.
· Poor
longitudinal weight gain
· Elevated
arterial oxygen tension is also thought to contribute. However, ROP is not
the only consideration in determining the optimal target oxygen level in
preterm infants. Excessive reduction of target oxygenation saturation has been
associated with increased mortality.
· Infection may
worsen the course of ROP.
Breast milk feeding
appears to play a protective role in preventing ROP.
Infants with trisomy 21
appear to be at a lower risk for ROP compared with other infants
The optimal
SpO2 for preterm infants who receive supplemental oxygen therapy has not
been fully established. Based on the available evidence, the most prudent
target range for SpO2 in preterm infants is between 90 and 95%. This range
minimizes both the low and high extreme oxygenation levels that have been
associated with adverse outcomes and mortality.
Oxygen to a newborn is not decided by % of oxygen
but by the SPO2 levels
· Based on the
available evidence the current recommendation is a target oxygen
range from 90-95% resulting in minimizing extreme oxygenation levels for all
preterm infants
· This target
range appears to be safe for preterm infants ≥28 weeks gestation.
· In the most
mature preterm infants (gestational age >34 weeks), the risk of ROP
decreases and the upper limit can be increased to 97%.
· There is also a
paucity of data regarding oxygen target ranges as the preterm infant advances
in age. However, by 2-3 weeks postnatal age, the risk of intermittent hypoxia
increases, which may aggravate ROP by enhancing retinal proliferation. As
a result, with advancing age one should typically raise target
saturation to >95% if the infant still needs supplemental oxygen when the
corrected PMA is >32 weeks.
· Targeted
SpO2 levels of infants with congenital heart disease, BPD, or pulmonary
hypertension are individualized based upon the clinical status of the neonate
due to the paucity of data regarding optimal oxygenation for these
disorders.
Opinion
At the most it can be
difference of opinion. It does not appear to be negligence unless oxygen was
given without measuring SPO2 levels.
What can be done?
· Challenge in
the higher consumer forum
· Defence: Give
opinion of experts and published literature
Dr KK
Aggarwal
Padma
Shri Awardee
President
Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)
Group
Editor-in-Chief IJCP Publications
President
Heart Care Foundation of India
Past
National President IMA
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