PEDIATRICS

The major contributory factors for neonatal death are :

Prematurity

Severe asphyxia

Sepsis

Lethal Congenital Malformations

There is always social pressure as well as medicolegal issues to salvage every live born which may not be always in best interest of patient or family in the presence of factors which may lead to meaningless life or cause a significant burden on caretakers, families and society.

Intensive Care Practices deals with 3 issues:

1) Medical: Issues involves actual medical management  and clinically related issues.

2) Ethical: Involves to take right decision while maintaining patients interest in all apsects.

3) Legal: Issues involves maintaining standard care practice and providing honest and actual information to parents and care takers.

Neonatal Units face medicolegal issues due to :

• Negligence: 

Can be an issue for preventable illness eg inadequate treatment of neonatal hyperbilirubinemia in which delayed diagnosis or treatment of jaundice can lead to life long handicap due to Kernicterus which is avoidable condition . Negligence in this case can be due to :

Failure to screen and identify high risk babies; 

Failure to follow up babies who are discharged early;

 Failure to initiate phototherapy in time; 

Inadequate intervention in the form of intensive phototherapy and exchange transfusion

• Misdiagnosis:

Can be a problem in case of perinatal asphyxia where there is failure to pick up timely foetal distress and intervention; which can result in death or permanent disability.

• Wrong treatment/ Malteatment:

Can occur in various forms such as wrong medications, dosages, intravenous therapy complications, injuries , burns , infections, Severe retinopathy of prematurityetc.

• Death or permanant Disability

• Lack of consent:

Sometime interventions are done without consent or proper explanation or need of some investigations or treatment to the parents which can lead to medicolegal issues.

Conditions arising where Negligence counts:

1) Perinatal Asphyxia: 

When baby suffers this, several issues may arise regarding antenatal management and subsequent postnatal issues.

Questions may be asked in view of case if found negligent are:

Cause of asphyxia?

Whether timely intervention was done?

Was it preventable?

Criteria of asphyxia fulfilled?

Any supportive evidence available eg. Cardiotocography tracings, Partogram, Scalp pH or lactate.

Other documents like Placental examinationn to rule out chorio- amnionitis, thrombosis, infarcts or any other evidence of metabolic disease?

MRI changes and type and timing of injury?

For any litigation all the above points are very relevant. However after severe asphyxial insult if the baby develops severe encephalopathy which can lead to lifelong disabilities, questions arise regarding continuation of intensive care, ventilation and other life sustaining care.

2) Resuscitation of extremely low birth weight (ELBW) babies: 

This is another important issue where a significant medico legal argument can arise. There are no legal guidelines of cut off gestation for limits of viability in our country. American Academy of Pediatrics (AAP) recommends in confirmed GA below 23 weeks and birth weight < 400 grams, anencephaly, confirmed trisomy 13 and 18 syndromes, possible 23-24 weeks gestation if parents do not want resuscitation, it is ethical not to initiate resuscitation?

 However in India there are no laws which either say not to resuscitate or withdraw resuscitation.
Recently National Neonatology Forum (NNF) has come up with guidelines which recommends this cut off may be considered as less than 25 weeks gestation. However it may not be always appropriate to follow a cut off without evidence for taking such decision. The decision should depend on the local data on outcome at various gestations (both mortality and morbidities and long-term neurodevelopmental outcome) as well as availability of expertise and infrastructure and parental support for long-term issues in these survivors.

3) Care of babies with major malformations/disorders: 

Major malformations/disorders which are either not compatible with life or associated with severe morbidities also pose a medicolegal issue whether to resuscitate these babies and to continue care or not. In such cases parents should be given a detail information regarding malformation details and their outcome regarding prognosis, cost details, quality of life, extent of family care required etc. Extended family can be involved in decision making and decision whether to resuscitate or not can be planned well before delivery and written consent should be obtained for further treatment plans. All discussion must be well documented and signed by parents, medical team and witness.

4) Complications like severe grades of intraventricular hemorrhage (IVH) in preterm babies:

 Some extremely preterm babies or babies with significant illness can develop severe grades of IVH or extensive periventricular leucomalacia (PVL) which can be associated with short-term as well long-term neuromorbidities. In such cases again continuation of intensive care become a difficult decision for both the medical teams as well as parents.

END OF LIFE (EOL) DECISIONS IN NEONATES:

The end of life decisions in neonates is one of the most difficult situations for both parents and medical team due to ethical and legal dilemmas attached to it. A very effective communication system must exist between both sides to take such a decision.

The three most common neonatal situations which may require EOL decisions are:

1. Fetuses at the lower gestational age/limit of viability

2. Neonates with life threatening/life limiting congenital malformations and syndromes

3. Acutely ill newborn in intensive care with very poor prognosis.

Ethical Principles

While taking decisions for BOL in any critically sick patient, four ethical principles must be followed :

1. Autonomy of the patient

2. Beneficence

3. Non-malfeasance

4. Distributive justice

Autonomy means an individual's rights of freedom and liberty to make changes that affect his or her life. In pediatric and neonatal patients either the parents or a legal guardian can take such decisions.

Beneficence is acting in what is (or judged to be) in patient's best interest. In critical care, the physician is expected to care for patients with a high risk of death. The physician's expanded goals include facilitating (neither hastening nor delaying) the dying process, avoiding or reducing the sufferings of the patient and his family, providing emotional support and protecting the family from financial loss. Parents also can be guided for financial help from charitable trusts, free government or insurance schemes.

Non-malfeasance means to do no harm, to impose no unnecessary or unacceptable burden upon the patient. In practical terms, it requires the physician not to act contrary to the patient's values and perspectives.

Distributive justice means treating patients truthfully and fairly. Physicians need to take a responsible decision and to make good use of the infrastructure, financial and human resources under their control. The physician may thus provide treatment and resources to one with a potentially curable condition over another for whom treatment may be futile.

In cases of resuscitation of newborn, the autonomy of newborn and to take decision in life-threatening emergency situations is both exceptions of general rules of ethics.

Legal Dilemas in End of Life Decisions:

To be certain about prognosis:

A reasonable amount of certainity is required to take decisions regarding end of life because the probability of dying is not always clear. Manier countries have set guidelines about when to initiate EOL decisions however in our country there are no legally adopted guidelines. EOL decisions may arise when patients are " approaching the end of life" when they are likely to die within next 12 months .This includes the patients:

• Whose death is expected within hours or days due to underlying disease Who have advanced, progressive, incurable conditions

• Those with advanced age and co-existing chronic poor morbid conditions which can lead death within 12 months

• Those at risk of dying acutely in an existing condition & Those with life-threatening acute conditions caused by sudden catastrophic events

• In extremely preterm neonates whose prospects for survival are known to be very poor

• Patients diagnosed as being in persistent vegetative state for whom a decision to withdraw treatment and care may lead to their death.

The decision of EOL needs significant expertise and experience. Sometimes physician's opinion could be biased and depends on own attitude towards life. End of life decisions are different and difficult in Pediatric and neonatal patients due to emotional attachment to parents as children are in the beginning of their life. Sometimes communication gap between doctors and parents can also lead to misinterpretation.

EOL Decision in Limits of Viability

In cases of EOL decisions or do not resuscitate (DNR) orders in delivery room in cases of limits of viability could pose legal issues. It is sometimes difficult to ascertain the exact gestation before delivery because the methods by which gestation is assigned are not always foolproof unless it is in vitro fertilization (IVF) pregnancy. 

Obstetrical dating is accurate up to + 1 week and estimated fetal weight could vary between + 15-20%. This is extremely important for preterm gestation as 1-2 weeks of GA or 15-20% weight difference can lead to significant difference in mortality and morbidity predictions however it does not make any difference in cases of term pregnancy.

Ethical Dilemma in EOL Decisions

Who Takes Decision if Patient is a Newborn or Minor?

As pediatric and neonatal patients are not competent to consent to medical treatment, and therefore require surrogate consent. Though older children and adolescents are/ can sometimes be part of decision making but neonatal patients always need surrogate decision makers.

Though it is almost universally accepted that parents decide about the treatment of newborn/ minor, but conflicts may arise in certain situations when parents' decisions are detrimental to the health of newborn. This situation is often faced when moral and religious beliefs of the parents prevent them taking end of life decisions.In India there are no clear cut guidelines.

In USA usual legal options are either a court appointed legal guardian to replace parents or to take the temporary custody of the child and to involve child care services. On the other side, situation may arise when medical team wants to continue treatment but parents refuse to do so. 

In our country many a times parents would ask physician to take the decision. Though the above situations can be solved to a great extent by effective communication rather than opting legal options.?

The effective communication should include:

• Detalls of prognosis of the condition (known and unknown) both short-term and long-term explained to parents in local language.

• Comprehensive understanding of the existing condition by the parents.

• Explanation and providing comfort care to dying baby

• Discussion about Mode of EOL which are

Do not resucitate

Withhold Life sustaining Treatment

Withdraw LST

Natural Death implies death occuring despite maximal intensive care.

Various Medico legal Negligence issues arising out of all Paediatrics Care against the Doctor or for the welfare of patient can be Contacted at www.legalmedicine.in