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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.
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
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
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.
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