Caffeine citrate: New 'gamechanger' drug in saving lives of preterm and low-birth babies

There is hope in reducing infant deaths in Kenya, following the adoption of a drug that manages breathing problems in newborns.

The Ministry of Health has adopted the use of caffeine citrate in the management of apnoea prematurity.

Apnoea of prematurity is when a preterm baby pauses breathing for more than 20 minutes, and has a slow heart rate and low oxygen level.

Experts note that babies must breathe continuously after birth, but for preterm babies, the part of their brain and spinal cord that controls breathing is not mature enough, and sometimes they can 'forget' to breathe.

Lack of breathing therefore risks respiratory failure and death.

In the deal struck by Clinton Health Access Initiative (CHAI), and drug manufacturer Ethypharm, Kenya will get the commodity at 70 per cent subsidised rate compared to before as the commodity will retail at Sh400 per ampoule, a significant drop from the initial Sh1,500.

The deal was struck at a time when Kenya is recording stagnated neonatal death, at 21 deaths per 1,000 live births, which accounts for 51 per cent of under-five deaths.

Health CS Susan Nakhumicha applauded the move, saying the drug will be a game changer in managing preterm births.

"I am happy to share that the ministry has finalised the development of Apnoea of Prematurity using Caffeine Citrate and Continuous Positive Airway Pressure (CPAP)," said Nakhumicha.

She added, "I want to thank Clinton Health Access Initiative (CHAI) for supporting the efforts for successful negotiation for the 70 per cent reduction in access price for caffeine citrate in Kenya"

Health CS said the drugs will be supplied to public hospitals, through Kenya Medical Supplies Authority (KEMSA).

Ethypharm donated 10,000 ampoules while CHAI donated 20,000 ampoules of caffeine citrate to Kenya Medical Supplies Agency, valued at Sh13.5 million to boost its access.

Caffeine Citrate is WHO-recommended in the treatment of prematurity apnoea.

In an interview with The Standard, Ethypharm general manager, of Middle and North Africa Rob Bruchet, said the supply of the drug at a lower price will boost child care.

"We are very happy to be able to do partnerships here in Kenya. Accessibility to the product really makes a difference with babies and parents. We want to create happier families here in Kenya," said Bruchet.

He said Ethypharm will collaborate with its local distributor Laborex Kenya to ensure the drug is distributed to hospitals with the highest quality and standards.

Reuben Kiptoo Sigey, Regional Manager Nothern Sub-Saharan Africa at Ethypharm said the drug is a stimulant that targets the brain of a newborn.

Once delivered to the brain, the drug stimulates various muscles in the body for neonates.

"It (caffeine citrate) targets smooth muscles of the heart to increase pumping, and brain stem cells that helps babies to remember they need to breathe," said Sigey in an interview.

He added, "Once it is administered, it makes neonates remember to breathe,"

Sigey explained that the brain of a preterm born before 34 weeks of gestation is not fully developed.

Due to undeveloped brains, the babies experience episodes of problems breathing, but once caffeine is administered, they breathe normally.

The drug is administered every day, as per WHO guidelines, until they have improved breathing rates.

He noted the need for Kenya and the African continent to build strategic infrastructure within neonatal care units to avoid infant deaths.

With the partnership, he said there will be wider use of the drug, at cost-effective prices.

"As it is with any medication when you get wider use and wider volumes, it allows you to bring your costs down.

The partnership is very strategic in our regard because it allows us to focus on larger volumes, find ways of producing the drug at a lower cost level, and deliver the drug to the Kenyan people, and in other countries as well," said Bruchet.

In line with the 2022 WHO recommendations for care of the preterm or low birth-weight infants.

Kenya has championed the development of apnoea of prematurity guidelines, which is critical for all secondary-level newborn units in Kenya.

The guideline expounds on the prevention and treatment of apnoea of prematurity using caffeine citrate.

Further, the guidelines outline the pharmacological and non-pharmacological management of apnoea of prematurity such as the use of caffeine citrate, bubble continuous positive airway pressure and Kangaroo Mother Care.

In the neonatal guideline manual, nearly all pre-terms less than 28 weeks' gestation, 85 per cent of preterm born at 30 weeks' gestation and 20 per cent of those born at 34 weeks' gestation develop apnoea of prematurity.

For effective uptake of the management of apnoea of prematurity national guidelines in Kenya, according to the Ministry, there is need to have a strong commitment is paramount at the national and county level in rolling out recommended interventions.

"In addressing commodity security gaps, the Ministry of Health is supporting rigorous market shaping efforts, which are yielding great progress in strengthening the availability of affordable caffeine citrate," notes the ministry in the guideline manual.

Other aspects such as the use of bubble continuous positive airway pressure therapy and pulse oximetry in neonates have been included.

Director General Dr Patrick Amoth said the guideline will lay a strong foundation for increased investments towards caffeine citrate commodity security and strengthen the availability of essential equipment and supplies in the newborn units.

"The scale-up of recommended practise in the prevention and treatment of apnoea of prematurity will enable the country to accelerate the reduction of neonatal mortality," noted Dr Amoth in the guideline manual.

Amoth added that though Kenya has significantly reduced mortality among children below five years, newborn deaths remain high.

Data reveals that from 2014 to 2022, the under-five mortality rate decreased from 52 to 41 deaths per 1,000 live births, and the infant mortality rate from 39 to 32 deaths per 1,000 live births.

However, neonatal deaths decreased at a slower rate from 22 to 21 deaths per 1,000 live births.

"Neonatal deaths account for 66 per cent of total infant mortality and 51 per cent of total under-five mortality. Most neonatal deaths (75 per cent) occur during the first week of life," said Amoth.