Preterm babies don’t gain growth by early initiation of complementary food

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Babies started early on complementary food tend to suffer more due to diarrhoea and lower tract infections.

Babies born preterm (before 37 completed weeks of gestation) have a higher energy requirement than babies born full term and therefore fail to gain weight adequately. Parents of preterm babies and doctors alike are not sure whether breast milk or formula milk alone will meet the energy requirements after the first four months and whether preterm babies should be started on complementary food. While normal babies are given solids and semi-solids only from six months of age, early initiation of complementary food, which has a higher calorie density, in preterm babies appears to be a good idea to meet their energy needs and improve their growth (weight and length).

Till recently there was little evidence of whether earlier introduction of complementary feeding (prior to six months of corrected age) would improve growth of preterm babies.

No gain in growth

A study published a few days ago in The Lancet Global Health has found an answer to this vexatious issue — early initiation of complementary feeding in preterm babies born before 34 weeks of gestation does not improve growth.

Doctors from the All India Institute of Medical Sciences (AIIMS), Safdarjung Hospital and Kasturba Hospital, all in New Delhi, enrolled 403 babies born before 34 weeks of gestation and randomly assigned them to two groups — one in which they were started on complementary feeding at four months of corrected age and the other group of babies where complementary feeding was initiated at six months of corrected age. The corrected age refers to age that is corrected for the period of prematurity — for a baby born at 32 weeks of gestation, which is approximately two months earlier than the normal gestation period, the corrected age is 10 months at the end of one year of birth.

Complementary feeding was standardised in both the groups in terms of frequency, consistency, type of food, preparing food hygienically, and ways of feeding. Complementary foods were given in addition to breastfeeding/other milk feeding.

“Even though one group of babies was started on complementary feeding at an earlier age of four months of corrected age, there was no difference in growth compared with babies who were started on complementary feeding at six months of corrected age,” says Dr. Ramesh Agarwal from the Department of Paediatrics at AIIMS, one of the corresponding authors of the paper.

Some health risks

On the other hand, the study indicates that early initiation of complementary feeding had some negative fallout. “There were more hospitalisations in the group that started on complementary feeding at four months of corrected age,” he says. Though overall hospital admission in both the groups was low, babies in the four-month group were at increased risk of hospital admission due to diarrhoea and lower respiratory tract infections. “There could be several reasons for this increased risk, including potential contamination of complementary foods due to inadequate hygiene or having less breast milk,” he says.

“Our study shows that there is no difference in growth whether complementary feeding is started at four or six months of corrected age. But there are more infections when complementary feeding is started earlier. So it is advisable that complementary feeding is started only at six months of corrected age in preterm babies less than 34 weeks of gestation,” says Dr. Agarwal. However, studying the difference in growth and not infection was the primary objective of the study.

Published in The Hindu on May 7, 2017

An App for cardiovascular management shows promise

Researchers have found a way to improve the quality of primary care and clinical outcomes cost-effectively by using a smart phone application for cardiovascular management program (SimCard). A trial was conducted in India and China. The study, which is the first dual-country trial of its kind worldwide, was delivered by community health workers and is ideal in resource-constrained settings.

The trial carried out in 20 villages in Haryana, and 27 villages in Tibet used a mobile app that focussed on two lifestyle modifications (smoking cessation and salt reduction) and use of two medications (blood pressure lowering agents and aspirin).

The trial increased the adherence to anti-hypertensive medications by 25.5 per cent in the intervention group. However, the uptake of aspirin medication was more in China (24.5 per cent) than in India (9.8 per cent. Similarly, a “significant net reduction” of over 4 mm Hg in systolic blood pressure was seen in China; there was no significant reduction in the case of India.

Over 16 per cent increase in the proportion of high-risk patients receiving monthly follow-up was seen in both countries. However, no changes in lifestyle were seen in the 2086 individuals with high CVD risks — over 40 years old with a self-reported history of CVD and a measured systolic blood pressure over 160 mm Hg. The results were published recently in the journal Circulation.

The study was carried out by the Public Health Foundation of India (PHFI), Delhi in collaboration with the All India Institute of Medical Sciences (AIIMS) in India and The George Institute for Global Health at Peking University Health Science Center in collaboration with Tibet University in China.

Published in The Hindu on August 23, 2015

Editorial: Neutralising diarrhoea, a mass killer

The curiosity and keen observation shown by a single doctor at the All-India Institute of Medical Sciences in New Delhi in 1985, combined with unprecedented team work by people from 13 institutions, both in India and abroad, would soon start annually saving the lives of thousands of children aged less than five years from a mass killer — rotavirus diarrhoea. In India, the disease annually kills over 100,000 children below the age of one, making the country account for a quarter of all global deaths caused by rotavirus diarrhoea. The majority of instances of the disease caused by the virus occurs during the first two years of age. According to results published recently in The Lancet, a Phase III trial of an indigenously developed rotavirus vaccine 116E carried out in three centres was found to be safe; it had 56.4 per cent efficacy in preventing severe rotavirus gastroenteritis in infants during their first year of life. Though the efficacy of the vaccine is only modest, it is superior to currently available ones. In the case of high-burden countries like India, even the modest efficacy of the vaccine would go a long way in reducing the number of deaths. The efficacy would further shoot up when widespread immunity is achieved through sustained vaccination of a majority of infants. Hence, there is a real possibility of the number of deaths dropping sharply in a few years after the introduction of the vaccine. It can also bring about a major reduction in the number of instances of hospitalisation in those aged below five, within two years of its introduction.

The vaccine, which would be made available to the government at not more than $1 a dose, is expected to be licensed shortly. It is imperative that the government quickly includes it in the national immunisation programme. The fact that three doses can be co-administered with other vaccines during the routine immunisation schedule makes it all the more attractive. While it is true that improving sanitation and hygiene levels is insufficient to rein in rotavirus diarrhoea, there is a compelling need to improve social infrastructure in order to control other pathogen-caused diseases like cholera. Besides the direct benefits from the vaccine, the isolation of the human neo-natal rotavirus strain and the conduct of clinical trials in India have given the science of vaccine development a much-needed boost. Though it has taken nearly 30 years to reach this stage, the development of this vaccine proves that Indian companies can take to completion clinical trials of novel drug candidates. In fact, the government should adopt the same model to develop drugs for other neglected tropical diseases that primarily affect people living in poverty in the developing countries.

Published in The Hindu on April 7, 2014

Of `miracle cures’ and misleading news reports

Published in The Hindu on December 8, 2005

“Believe nothing that you see in the newspapers… if you see anything in them that you know is true, begin to doubt it at once.”

Sir William Osler

Are you taken in by a news report that a drug, surgery, therapy or a particular diagnostic tool, the `first of its kind’ in Asia/India, is the solution you have been waiting for, for years? Or have you already taken the clipping to your doctor demanding that the new drug be prescribed and has your doctor either willingly or on being forced yielded to your demands? Or, as is common in India, have you headed straight to the chemist’s shop or hospital to buy the medicine or undergo the diagnostic test?

“… Patients often arrive at their appointments with news articles and Internet printouts in hand,” noted an editorial published in the reputed The New England Journal of Medicine (December 2004). Unfortunately, it is not just lay readers who depend on the lay press for medical information. “… Physicians, too, now rely in part on the media to learn about new studies, especially those outside their own specialty areas,” the editorial commented.

If you have based your decision as a patient to either buy or force your doctor to prescribe the drugs based on news reports, chances are that you would soon regret your decision. The Fen-pen drug incident will tell you why.

Fen-pen fiasco

The Fen-pen was hailed as the miracle cure for obesity in the 1990s. But in 1997 it was withdrawn from the market due to the damages that the drug caused to heart valves. What started as a stampede at shops when the drug was introduced, finally culminated in lawsuits totalling $13 billion from consumers!

Much like the phoenix rising from its ashes, Fen-pen made a comeback soon, thanks to pliant media and medical journals. One year after the drug was withdrawn, the USA Today reported that that the drug caused no heart damage, recalled Dr. Anoop Misra, Professor, Metabolic Research Group, Department of Internal Medicine, AIIMS, New Delhi.

Though the report made a mention that a pharmaceutical company paid for the study and the treatment was only for three months, what went unmentioned was the fact that the article was based not a full report but an abstract presented in a conference!

Operation manipulation

The USA Today report attracted more media reports that painted a rosy picture of the drug.

That was not the end though. Despite the fact that The New England Journal of Medicine wanted the authors to modify the analysis of the paper sent to it, the Journal of American College of Cardiology (JACC) published the article without any changes. And a report in the New York Times gave a clean chit to the drug. The catch with the paper published in JACC was that one of the authors was paid by the pharmaceutical company.

“The editorial in the same journal also supported the drug,” he noted. The fine print conveyed a different message — it was written by a consultant to Home Products that was part of the pharmaceutical company that owned Fen-pen.

Editorials in journals and peer-reviewed journals in particular are widely respected by journalists and the lay readers. The New England Journal of Medicine (NEJM)’s policy to ensure that its editors have no financial ties with pharmaceutical companies or those about whom they are writing is not followed universally.

“For private companies, publication and a positive press have cash value,” an editorial in NEJM cited (December 2, 2004). “… Policies such as ours ensure that editors remain free of financial ties to those whose work they publish.”

Dr. Misra brought the Fen-pen issue to the attention of journalists writing on health and medicine related issues during a workshop conducted by Health Essayists and Authors League (HEAL) in Jaipur recently.

The editorial in the Annals of Internal Medicine (February, 2004) starts with Sir William Osler’s quote and goes about to point out the areas of concern leading to distorted reporting of health issues in lay press.

Need for caution

The editorial urged journalists not to report the findings of Phase I trials and those presented at scientific meetings.

If journalists are duty bound to mention about the nature of the findings, readers may do themselves good by not giving much credit to such reports even if the results appear promising. “Promising reports often fail to pan out and methods, results and interpretations change over time,” the editorial cautioned.

It is important for readers to understand the significance of the results derived from a study involving a small number of volunteers or when the study has been conducted for a short duration.

Though results from such studies may appear promising, they may not stand scrutiny or achieve repeatability in a large scale trial.

There is no magic cure for any disease and if any report claims so, readers may well remember not to take it on the face value. No drug or procedure is without drawbacks or side-effects.

It is time readers understood this basic tenet and did not get fooled by reports that refrain to mention these details.

This is not to shift the responsibility to readers but to help them not to get swayed or carried away by news reports that are peppered with tall claims.

The conflict of interest such as authors being financed by companies whose products they are studying, or being an employee of the company should alert the media and readers alike.

 

Unsafe injections, fatal infections

Published in The Hindu on September 22, 2005

About 40 per cent of the 16 billion injections given in the year 2000 in the developing countries alone had used unsterilised injection devices leading to the spread of blood-borne virus infections — 41 per cent hepatitis C infections, 30 per cent hepatitis B infections and 5 per cent HIV infections. These figures come from one of the most authentic sources — the World Health Organisation.

The paper published in the British Medical Journal (September 2005) points out that the reuse of unsterilised injection devises in the South East Asian region was as high as 75 per cent. And the risk of HIV infection through contaminated injection devices in South Asia, according to the WHO, may be as high as 9 per cent.

Unsafe injections

The results of the study undertaken by the Indian Clinical Epidemiology Network and AIIMS, Delhi and supported by the Union Ministry of Health and Family Welfare and the WHO point out that 63 per cent of injections in India are unsafe. Of this, nearly one third carry a risk of transmitting blood-borne viruses.

Unsafe injections are those that use faulty techniques for administering injections and expose the recipient to avoidable risk of infections.

This highlights the compelling need to include safe injection practices in addition to safe sex to keep HIV and hepatitis infections at bay. “It’s so easy to fix and so inexpensive to do,” Mr. Yvan J.F. Hutin the lead author of the paper published in the British Medical Journal was quoted as saying in the New Scientist (November 2003).

Though the global incidence of HIV through contaminated injection devices may be 5 per cent, and 9 per cent in the case of South Asia, the figure quoted for Africa hovers around 2.5 per cent. The low figures quoted for Africa has been hotly debated and contested though.

Looming threat

The study undertaken in India, which was also supported by the WHO, clearly points out a much higher possibility of HIV infection (compared with Africa and possibly in line with the South Asian figures) from contaminated needles and syringes.

While many reasons have been ascribed for the low figures being quoted for the African region, one of the reasons is the fear of the focus being shifted from safe sex to contaminated needles and the repercussions thereof. That is no reason why the high figures cited in the Indian study should lead to any dilution of already existing prevention strategies.

On the other hand, the findings should enable us in India to arm ourselves for better protection from all possible sources of infection. And central to this is the role of the patient and the doctor in avoiding unnecessary injections. The quick relief provided by injections is the most often cited reason for patients insisting for them even when they are totally unnecessary. Doctors, on their part, are only too willing to oblige, knowing the psychological relief that injections provide but unwittingly expose patients to potential risks.

The majority of therapeutic injections in developing countries are unnecessary, according to the WHO.

“… for AIDS, unsafe sex is by far the biggest risk. Injection safety is not the driver of the HIV epidemic. There is no good data to support it,” Dr. Hutin the lead author of the paper published in the British Medical Journal was quoted as saying in the New Scientist (November 2003).

Dr. Schmid shares Dr. Hutin’s views. “We do think the focus should remain on safe sex,” Dr. George Schmid, a senior HIV researcher with WHO in Geneva, was quoted as saying in the New Scientist (February, 2004).

Auto-disable syringes

That the WHO, UNICEF and UNFPA had recommended that all countries use only auto-disable syringes in immunisation programmes starting from 2003 and the advice that all countries use single use injection devices for therapeutic purposes underlines the importance attached to preventing the spread of infections through contaminated injection devices.

Though belated, the Union Ministry of Health and Family Welfare has made the use of auto-disable syringes mandatory for immunisation programmes. This simple measure will go a long way in making sure the chances of HIV or other blood-borne infections are eliminated in the child immunisation programmes.

However, the mandate includes only government health facilities. Making it mandatory for all private immunisation centres to use only auto-disable syringes will go a long way in reducing infections.

The use of combination vaccine for immunisation programmes will further help in not only reducing the expenses but also go a long way in reducing the risk of unsafe injections.

Preventing misuse

The doctors and patients’ onus does not end by ensuring the use of sterilized injection devices. Making sure that syringes and needles are destroyed to prevent possible misuse should also be high on the priority list, lest the used syringes and needles are either reused on someone else or is sold to rag pickers, who in turn form a part of the chain that enable the entry of contaminated syringes and needles into the market.

Avoiding the use of glass syringes even when they sport disposables needles, insisting on disposable syringes and needles and if possible using auto-disable syringes will go a long way in curbing the spread of blood-borne infections. It may be borne in mind that the study found that glass syringes are 12 times more capable of causing infections.

The main reason is the inadequate sterilization and gross ignorance on the correct ways of sterilising glass syringes. “Written guidelines for sterilisation were available at only 10 per cent of all health facilities across the country. It was disturbing to note that more than half (56 per cent) of the prescribers reported an incorrect sterilisation process,” the report stated.