I do not consider myself to be the EXPERT on the subject.

I consider the talk more of reflection on Neonatal Practice in General.

I have referred various resources for the presentation

I have no conflict of interest.

"No other gift is greater than the gift of

life! The patient may doubt his relatives,

his sons and even his parents, but he has

full faith in his physician. He gives himself

up in the doctor's hands and has no

misgivings about him. Therefore, it is the

physician's duty to look after him as his

own". (Charak)

Ethics refers to moral principles or set of moral values that determine the conduct of doctors as stipulated by the medical profession from time to time.

“A physician should be an upright man... He shall keep himself pure in character and ...he should be modest, sober, patient, prompt in discharging his duty without anxiety; conducting himself with propriety in his profession and in all the actions of his life.”

Ethics Requires that we treat people as ends and never simply as means or as subjects, and never simply as objects - Immanuel Kant

beneficence

Non maleficence

Parental autonomy

Distributive justice

correct medical facts

Who benefits from my action and in what way?

doing good

preserving life and alleviating suffering

Primum non nocere

Which parties may be harmed by my action?

What steps can I take to minimise this harm?

Have I communicated risks involved in a truthful and open manner?

In the event of a disaster, how can I avert the possible harm caused?

respect parental autonomy and family privacy

presumptive authority over the welfare of their children.

Strong ties of affection and concern

insight into the functioning of their family

an ongoing role in their children's lives.

The treating team

- less likely to be vulnerable to the stress and emotional turmoil

- wide range of nonmedical issues involved

Shared decision-making between parents and physicians - ideal strategy

Have I identified all vulnerable groups that may be affected by my action?

Is my proposed action equitable?

How can I make it more equitable?

- protect patient rights

- fair allocation of medical resources

Medicine is about : “Can we?”

Ethics is about: “Should we?”

At three junctures -

resuscitation,

treatment planning,

and withdrawal of treatment.

Apply three basic ethical concepts: Do no harm. Act in good faith. Act in the patient’s best

interest.

Ethical Issues in Neonatal Medicine

• Limits of viability: 22-24 wks GA• Congenital anomalies

– Prenatal- Fetal surgery

– Postnatal - genetic, multiple anomalies• Nonresponsiveness to therapy

– Chronic lung disease– Perinatal distress– Intraventricular hemorrhage

Gestational Age Recommended Care(completed weeks)

<23 (24) weeks DNR

23-24(24-26) weeks Comfort care

Resuscitation only if family wishes support after outcomes discussed; comfort care may be chosen

> 26 weeks full Resuscitation recommended

In the postsurfactant era, most commentators have recommended -

Initiating intensive care when the GA is 26 weeks or greater,

forgoing intensive care when the GA is < 24 weeks or less, and

providing care in accordance with the parents’ wishes when the GA is 24 – 26 weeks

not appropriate to initiate resuscitation for newborns less than 24 weeks’ or 500 g BW

Sophisticated, intensive care environment with aggressive interventions

In combination with

Patient/family-centered comfort and palliative care ?

“Ethical issues” are emotionally, physically and intellectually demanding

Often confronted by moral dilemmas

to which there are NO easy answers

and about which reasonable people

disagree

The goal of NICU care is NOT survival alone, but survival with an acceptable

quality of life

survival to discharge and survival without severe disability or impairment at follow-up.

Severe disability or impairment has generally been defined as the presence of cerebral palsy, blindness, deafness, or developmental-cognitive scores more than two standard deviations below the mean.

favorable outcome might be defined as

survival,

survival without severe neonatal morbidity, or

survival without impairment at 18 months

To the extent possible, the criteria used to identify these infants should be based on data

In, Which newborns NICU care should not be initiated?

Once initiated, should such care be withdrawn if severe complications occur?

Who should Decide?

Good ethics begins with good facts - Fost

Newborn Infants for Whom Ethical Decision-Making is Often Required

• Extreme prematurity (limits of viability

22-24 wks) morbidity (CNS, pulmonary)

• Full-term — severe perinatal asphyxia

• Genetic disorders (e.g., trisomy 13)

• Multiple congenital anomalies

Newborn Infants for Whom Ethical Decision-Making is Often Required

• Hypoplastic left heart syndrome, complex cyanotic heart disease

• Severe intraventricular hemorrhage

• Requirements for “high technology” (transplant, ECMO)

• Non-responsiveness to intervention (e.g., worsening chronic lung disease-ventilator dependent, short gut, sepsis)

Neonatologists are too eager to initiate intensive care,

too reluctant to withdraw such care,

and too hesitant to involve parents fully in treatment decisions

death following a prolonged period of suffering is clearly a worse outcome

some survivors, have of severe handicaps that many consider worse than death

The most “aggressive” neonatologists routinely initiate intensive care to any extremely premature infant, no matter how small or immature

The most “conservative” neonatologists, do not recommend intensive care before 25 or 26 wks GA

“Despite some chance of survival, intensive care may

not be preferable to comfort care and contact with the parents as they desire”

Neonatology lacks the “holy

grail” whereas an intervention/

approach to care will improve

survival and decrease the

prevalence of disability among

survivors

In an age of spectacular scientific progress, parents with gravely ill

children have never had more information or better medical

options…But when the possibilities seem endless, one choice becomes more

difficult to contemplate: whether to do nothing.

Marcus AD. Wall Street Journal. Dec 15, 2003

Non-Initiation / withholding Treatment

Consider

the risk of death

Pain and suffering caused by intensive care,

the future quality of life of survivors,

The views of the patient or his or her surrogates

The resource use and cost of care

Neonatology lacks the “holy

grail” whereas an intervention/

approach to care will improve

survival and decrease the

prevalence of disability among

survivors

We have NO right to impose experimental

therapies on newborn infants of 22 and 23

weeks’ gestational age in view of lack of data

demonstrating effectiveness of care

Ethics and the NICU

Vermont Oxford Network, 2004 Annual Meeting

The infected mother should be told about the risk of vertical transmission of HIV to her offspring

given the option for abortion if desired by her

should be encouraged to take an informed decision regarding breast feeding

The confidentiality should be honored and maintained at all costs

Should NICU facilities be denied if family can’t afford ?

Should fertility of the couple or gender of the child affect our ethical decisions?

Should a high-risk extremely LBW baby be taken off the ventilator to provide assisted ventilation to a more salvageable bigger baby?

What should be done when the family cannot further afford the expenses ?

Is it worthwhile to provide hi-tech and extremely expensive intensive care to a tiny baby of illiterate and economically destitute parents ?

complexity of care involved,

scientific uncertainty regarding outcome,

lack of medical and social consensus on ethical standards

the necessity for adequate social and physical resources

decisions to continue intensive care should be based on reasonable evidence that the benefits outweigh the pain and suffering to the infant and the use of expensive and limited resources.

Admission to an intensive care unit in a tertiary hospital can be a harrowing experience for the patient (and the family). IMPERATIVE that we periodically step back from the

bedside and decide what are our goals. Is there a REASONABLE CHANCE that all that is

being done will result in meaningful survival? If the answer is “NO” or “PROBABLY NOT”, then the

time has come to start discussing plans with the family to DISCONTINUE SUPPORT.

Alpert, JS Amer J Med2009; 122: 789-790

Follow the principal of Distributive Justice

acceptably cost-effective?

expenditures to preserve life are limited in every society.

selective use of intensive care for extremely premature infants results in a lower cost

The total costs per survivor at discharge are very high

These resource costs do not include the costs after discharge to the family

Medicine, Money and Morality clash

effects on the infant are of primary concern

consequences for all persons affected relevant

the effects on the family when there is little likelihood of benefit to the infant

principle of nonmaleficence should be applied to the family as well as the infant

effects on the parents’ marriage and family life

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Maternal ill health

Separation from her infant

Strange, “hostile” environment - ALIEN environment

High-tech noise, light

Unfamiliar staff

Complex medical disorders to understand

• Appearance, condition of infant

- tubes, wires, other

• Sudden unexpected changes

— two steps forward, one step back

• lack of control, uncertainty

• Lack of information

• Financial hardship

Lack of Information

Exclusion from Decision-Making

Overtreatment of Babies

Pain and suffering of treatment

“The NICU experience is like living through a nightmare that you just cannot wake up from”

“The NICU is full of numbers: As and Bs, grams per day, ounces of milk, q3 hours, % of oxygen, level of sodium,etc.”

“We constantly read research papers and abstracts, trying to digest the information.”

“Our lives revolved around the numbers, percentages and statistics regarding cognitive impairment, behaviourabnormalities and motor disabilities”

Compassion

Humility

Courage

Information

Honesty

Time

Sensitivity

Commitment

What parents require of the health care team

Despite the progress made over the past decade, scientific uncertainty regarding outcome continues in the neonatal intensive care unit.

“a vast uncontrolled experiment

undertaken without informed consent

and with possibly undesirable results.”

- Jeffrey Maisels

“ Intensive Care is like the withdrawal method of contraception, Best used early and certainly before physiology is irreversible ”

Layman unable to cope with data

Opinions not facts cause anxiety

Defensive medicine

Third party information

Parents should be told of the following:

(1) the probable outcome of the treatment plan,

(2) the existence and nature of risks of interventions or treatments

(3) information about any alternative treatments, including their potential for risks and benefits.

The parents should be kept informed about the condition

Humility, concern, empathy and compassion are crucial

The health team should not only try to do their best, but the family must perceive

The religious faith of the family should be honored

• Information given parents in the NICU often consists of euphemisms and half-truths.

• Parents are rarely informed about major uncertainties surrounding their babies care or allowed to participate in decisions.

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Press reports of the “worlds smallest baby”

without follow up or appropriate

discussion of problems [and]

costs (financial and emotional)...

...do nothing but create unreal expectations in parents and families.

Physicians who compete in the

lay press contribute to

- misunderstanding,

- malpractice and

- increased cost.

Parents of a ELBW Baby

During the ten years between Our baby’ birth and death, it seemed as if the doctors were slowly chipping away at his body and his spirit.

During those ten years, what stands out are the constant battles to find our baby help and treatment.

As his care became more difficult and unsuccessful, much of the medical community backed away in frustration. (contd--)

Parents of a ELBW Baby

Believe me, I felt the frustration too, but I spent the endless nights holding him while he cried in pain and asked me to make the hurt go away.

My greatest fears from ten years ago were realized:

that in spite of all the love and nurturing we gave Our baby , we could never take away the pain or make him well.

When Our baby was two, I was asked to bring her back to the NICU for a follow-up study.

At the time, she was being treated for cerebral palsy by a world- famous neurologist; for visual defects by a pediatric ophthalmologist; …for ear and throat problems by an ENT; for chronic pulmonary disease by a pediatric pulmonologist...

(contd--)

…for immune deficiencies by an infectious disease specialist; and for orthopedic problems by a pediatric orthopedist.

She was also receiving speech, physical, and occupational therapy.

(contd--)

However, for the purposes of the NICU follow-up study, She was declared

NORMAL!

“There is no excuse, no matter how well-intentioned, for withholding important clinical information about a child’s condition or prognosis from his or her parents.”

“David will be 9 on May 8. I consider this the ninth

year of my jail sentence. Even killers get out on

parole. Not the parents of micro-preemies, who

suffer brain damage from being intubated,

respirated, poked, prodded, bled and barely fed.

Hospital gets $500 K from our private insurance.

We get a life of broken dreams and sleepless

nights.”

Father of a micro-preemie

…We find the scenarios (of neonatologists)

for quality-of-life evaluations to be out of touch

with the harsh realities of our children’s lives.

Where is the description of the months or years of

grueling hospitalization with the associated

gastrostomy tubes, jejunostomy tubes, and

fundoplications; the tracheostomies, shunts, and

orthopedic, eye, and brain surgeries;

hyperalimentation, oxygen tanks and ventilators? (continued)

Similarly, there was no mention of

bankruptcies, divorces, mental and physical

breakdowns, death in late childhood,

neglected siblings, and suicides caused by the

extreme burdens of caring for severely

medically and developmentally compromised

children.Culver G, et al. JAMA. June 28, 2000

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The first step in the evolution of ethics is a sense of solidarity with other human beings.

— Albert Sweiter

initiate regular education programs in the field of

- behavioral sciences,

- communication techniques and

- medical ethics for the benefit of medical and nursing students.

Two New Neonatal Ethics Books

Have we - the practitioners of the art of healing – gained the world and lost,

if not sold, our souls?

Physician, heal thyself - please.

“Sorry I’m late, but they had me on life support for two months.”

Singh M , Ind J Ped ; 2003

Orzalesi M , Biol Neonate; 2005

Tyson JE , Clin Perinatol 30 (2003) 363– 387

Singh M , indian pediatr vol 271 33-april 1996