Little Smile https://littlesmile.org Mother and child care Thu, 11 Dec 2025 06:57:59 +0000 en-US hourly 1 https://wordpress.org/?v=6.9 https://littlesmile.org/wp-content/uploads/2022/02/little-smile-2-1-150x150.png Little Smile https://littlesmile.org 32 32 FDA approves clesrovimab for preventing RSV in infants https://littlesmile.org/2025/06/28/fda-approves-clesrovimab-for-preventing-rsv-in-infants/ Sat, 28 Jun 2025 05:44:12 +0000 https://littlesmile.org/?p=36

The FDA approved the monoclonal antibody clesrovimab-cfor for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns, Merck announced.

Merck said it plans to make the shot available for the 2025-2026 RSV season under the brand name Enflonsia. “RSV disease is the leading cause of infant hospitalization in the United States and can lead to serious respiratory conditions like bronchiolitis and pneumonia,” Octavio Ramilo, MD, chair of infectious diseases at St. Jude’s Children’s Research Hospital in Memphis, Tennessee, and principal investigator for Merck, said in a press release. “Enflonsia combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention to help protect infants from RSV.”

The approval was based in part on results from a phase 2b/3 trial in which one dose of clesrovimab reduced RSV-associated medically attended lower respiratory infections by 60.5% for 5 months compared with placebo, according to the release. It reduced hospitalizations by 84.3% through 5 months.

Clesrovimab is the second one-shot mAb to be approved for RSV prevention in the U.S.

In 2023, the FDA approved nirsevimab, which the CDC recommends for infants aged younger than 8 months who are born during or entering their first RSV season and are not otherwise protected because their mother was not vaccinated against RSV, has an unknown vaccine status or was vaccinated within 14 days of giving birth. The CDC also recommends nirsevimab for children aged 8 to 19 months who are entering their second RSV season and have certain risk factors for severe disease.

Unlike nirsevimab, which is dosed by weight, clesrovimab has a fixed dose regardless of infant size. Ramilo told Healio last fall that one dose of clesrovimab was sufficient at preventing severe RSV disease in high-risk children, including preterm infants and those with chronic lung disease or congenital heart disease, compared with five doses of palivizumab — an mAb that has wider global availability than nirsevimab.

According to the press release, the most common adverse events associated with clesrovimab were injection-site erythema, injection-site swelling and rash.

The CDC’s Advisory Committee on Immunization Practices is scheduled to vote on recommendations for clesrovimab at its June 25-27 meeting, although it is unclear who will be making the votes after HHS removed all 17 members this week.

Newborn-Baby-Vaccination
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The yellow colour of eyes or skin at the age of 3 days. https://littlesmile.org/2022/02/10/the-yellow-colour-of-eyes-or-skin-at-the-age-of-3-days/ Thu, 10 Feb 2022 10:11:48 +0000 http://littlesmile.org/?p=25 Continue reading]]>

Most of the time, it is physiological jaundice. Parents are more worried if they judge it in artificial light, particularly yellow light. The average normal serum bilirubin level on day three in breastfed babies is about 12.5 mg/100 ml, and in formula-fed babies, 11.25 mg/a00 ml.; normal upper level at three days of age is considered to be 15 mg/ 100 ml. This bilirubin level may peak on days 7 – 8, maybe more than 15 mg/dl, then gradually reduces to normal level in a month. Breastfed babies take more time to baseline their bilirubin level. This physiological jaundice is totally harmless and doesn’t require any treatment;. Indirect bilirubin is an antioxidant that protects baby tissues from excessive oxygenation. As a baby is suddenly exposed to a higher level of oxygen postnatally. 

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Posseting or bringing out milk https://littlesmile.org/2022/02/10/posseting-or-bringing-out-milk/ Thu, 10 Feb 2022 10:00:32 +0000 http://littlesmile.org/?p=15 Continue reading]]>

 It is normal for babies to bring out some milk after feeding. In the early days, it is because of adjustment to feeding. Later it is usually due to overfeeding. Some babies don’t tolerate formula or cow’s milk but retain mother feed. If the baby is passing adequate urine and growing well, it is of no concern. If vomit contains bile or blood or if urine is reduced or growth is not adequate, it should be looked into ASAP. Some babies learn to bring up milk to enjoy the sour taste. 

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Baby Crying a lot. https://littlesmile.org/2022/02/10/baby-crying-a-lot/ Thu, 10 Feb 2022 09:59:28 +0000 http://littlesmile.org/?p=13 Continue reading]]>

This is a nature’s attribute, which keeps parents awake at night to take adequate care of the baby. Also, most babies, while in the foetal stage, are more active during night hours and sleep in the daytime because of the rocking effect of the mother’s movement. It takes a few months for a baby to settle into a normal human sleep pattern. During the night baby may demand more frequently, maybe every 45 minutes to 90 minutes, they should be breastfed on every demand. If they sleep well during the day, everything is normal. If a cry is due to a medical problem, it will also keep them awake during the day. Usually, babies stop crying on receiving care or breastfeed.

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