Breast milk is universally recognized as the optimal source of nutrition for infants, providing a perfect balance of nutrients and bioactive components essential for growth, development, and immune support. It contains antibodies, enzymes, and hormones that help protect against infections and chronic diseases [1]. Exclusive breastfeeding (EBF) for the first six months of life is associated with reduced risk of gastrointestinal and respiratory infections, enhanced cognitive development, and long-term health benefits, including lower rates of obesity and type 2 diabetes [2]. The World Health Organization (WHO) and the American Academy of Paediatrics (AAP) advocate for EBF for the first six months, followed by continued breastfeeding alongside complementary foods for up to two years or beyond [3]. Breastfeeding also fosters a unique bond between the mother and infant, promoting psychological well-being and development [4].

Though breastfeeding is ideal, there are circumstances where breast feeding may not be possible or insufficient, necessitating safe and effective alternatives. According to the Indian Academy of Pediatrics (IAP) guidelines, these guidelines emphasize the importance of breastfeeding, recommending exclusive breastfeeding for the first six months, as per the World Health Organization. Continued breastfeeding with complementary foods is advised for at least 12 months by the American Academy of Paediatrics and the Academy of Nutrition and Dietetics. When breastfeeding is not feasible, infant formula serves as a substitute, designed to mimic breast milk’s nutritional composition. While prioritizing breastfeeding, these guidelines recognize the necessity of alternatives in certain situations. Infant formulas are recommended when breastfeeding is contraindicated, insufficient, or not feasible [5]. These formulas are designed to mimic the nutritional composition of breast milk, providing essential macronutrients, vitamins, and minerals to support healthy growth and development of the infant [6]. The IAP and WHO recommend using formulas under medical guidance, particularly in vulnerable infants, such as preterm or low-birth-weight infants. Infant formula feed can be used as a sole nutrition source during the first six months and as a supplement alongside complementary feeding up to 12 months of age [7].

There are many formula feeds which are available in the market today and OPTILAIT, a brand of Shalina Healthcare, is one of the formula feeds which is designed to provide a balanced nutritional profile that supports the growth and development of infants from birth till 6 months of age, particularly those in neonatal intensive care units (NICUs). In addition, it is given to the infants in whom breastfeeding is contraindicated & who are unable to receive sufficient feed. OPTILAIT incorporates essential nutrients, including proteins, fats, vitamins, and minerals, tailored to meet the needs of infants who cannot be breastfed. The formula contains whole milk powder, oleic sunflower oil powder, hydrolysed whey protein, casein, skimmed milk powder, maltodextrin, mineral mix, vitamin mix, taurine, nucleotides L-Carnitine, Fructooligosaccharides (FOS), Galactooligosaccharides (GOS) and contains no added Sugar [8]. Aiming to ensure that OPTILAIT (Feed formula) meets the highest standard of nutrition and safety, a research study was designed to assess the improvement in weight gain, head circumference, height & safety of OPTILAIT in infants admitted to the NICU in Luanda, Angola.

This study was a non-interventional, single-center, observational, prospective study conducted in accordance with routine clinical practice at the Neonatology department in Kapalanga Hospital in Luanda, Angola. The study involved 29 infants admitted to the Neonatal Intensive Care Unit (NICU) in Luanda, with data collection spanning over four weeks (28 days) from the time of admission.

After an appropriate consent infants who were born at term, singleton births, with a birth weight of ≥2500 grams, aged between birth and six months, and either not being breastfed or whose mothers had independently chosen exclusive formula feeding were enrolled. Exclusion criteria were congenital illnesses affecting growth, chronic malabsorption, significant prenatal or serious postnatal disease, minor parent(s), inability of caregivers to comply with study procedures, and no prior participation in any other clinical studies.

The primary endpoint for the study was growth expressed as weight gain in grams per day (Time frame 28 days). The secondary endpoints were growth in terms of body length body length (in centimetres), growth in terms of head circumference (in centimeters), compliance to study formula intake recording daily quantity consumed (in milliliters) in the feeding diary, and assessment of the occurrence of adverse events. All these parameters were measured from enrollment until infants are 28 days. Study nurse assisted to record all the relevant data as per the protocol requirements.

At the start of the study, baseline demographic details, including age, gender, pulse rate, respiratory rate, and method of delivery. Additionally, the weight, height & head circumference of each infant were recorded daily for the entire period of 28 days. The quantity of OPTILAIT consumed daily for the period of 28 days since the day of enrollment, and the daily dosage was adequately documented by the study nurse to ensure 100% compliance as per study protocol requirements. The use of Optilait was not part of the routine care before the patients were included in the study. Out of 29 participants enrolled in the study, 12 used the formula exclusively and 17 used the formula as a supplement. The mean dose of Optilait given to babies was 45.42 mL with a standard deviation of 18.92 mL per feed, per day. Adverse reactions to Optilait were documented separately. Microsoft Excel was used for data analysis, and basic statistical tests were applied to all efficacy measures. The primary efficacy data were analyzed using a paired t-test within the treatment group, with results expressed as mean ± standard deviation. A p-value < 0.05 was considered statistically significant. All statistical analyses were conducted using SPSS version 20.0.

Ethical Considerations: Informed consent was obtained by the investigator from a legally acceptable representative (LAR) before study enrollment of infants.

The OPTI-GROWTH study evaluated the efficacy and safety of the new infant formula (Optilait), in neonates admitted to the NICU in Luanda, Angola. The study demonstrated consistent improvements in key growth parameters, including weight, height, and head circumference, suggesting that Optilait effectively supports growth during infancy.

The findings indicate a steady increase in weight over the study period, with an overall weight gain of 39.06% from Day 1 to Day 28. Each interval showed statistically significant weight improvements (P < 0.001). Similarly, head circumference increased by 16.64%, and height increased by 14.17%, with progressive improvements observed throughout the study period. These findings suggest that Optilait may support growth and nutritional needs in neonates requiring formula supplementation, particularly in situations where adequate breastfeeding is not possible or sufficient.

The study also assessed the tolerability of Optilait, where it was found to be safe, along with being efficacious. Out of the 29 infants enrolled, 6 infants experienced adverse events, including reflux, jaundice, respiratory distress, difficulty swallowing due to prematurity, possible hydrocephalus, and abdominal cramps. While these cases were observed, it remains unclear if they were directly related to Optilait or underlying neonatal conditions. In spite of these adverse events, all 29 infants adhered to the prescribed intake, confirming good compliance.

Approximately 55.2% of infants required medications during the study period, primarily due to neonatal sepsis, neonatal hypoxia, prematurity, or protocol-based treatments. Despite these pre-existing or concurrent conditions, Optilait displayed significant improvement across all growth parameters.

The most common reasons for using infant formula were prematurity (20.69%), maternal factors such as working mothers (17.24%), and low breast milk production (10.34%). Other cases included maternal infections (HIV, Hepatitis B) and neonatal feeding difficulties. These findings highlight the importance of having a reliable infant formula for neonates who cannot exclusively breastfeed.

The growth outcomes observed in this study align with findings from previous research on infant feeding methods. Studies have shown that breastfed infants typically gain weight more slowly than formula-fed infants in the first year of life, with differences in weight patterns continuing even after introducing complementary foods. This is consistent with our observations, where formula-fed infants demonstrated significant increases in weight, head circumference, and height over the 28-day study period [9][10]. Moreover, research comparing growth patterns among infants fed different types of protein hydrolysate formulas indicates that the degree of protein hydrolysis can impact growth outcomes. A study observed that infants fed extensively hydrolysed protein formulas exhibited growth patterns similar to those of breastfed infants, whereas those fed intact cow’s milk protein formulas had higher weight-for-length z-scores. This suggests that the protein composition and processing of infant formulas can influence growth trajectories, aligning with our findings that the specific formulation of Optilait supports healthy growth [11].

The study provides evidence that Optilait is a beneficial alternative to breast milk for neonates requiring supplementation. The study focused on a clinically vulnerable population (NICU-Based Cohort), providing valuable insights into the role of this formula feed in infants with growth concerns. Also, it assessed multiple growth parameters (weight, head circumference, and height) to ensure a holistic evaluation of infant growth. Additionally, a 100% compliance rate indicates excellent tolerability of the formula, reinforcing its practical applicability in clinical settings.

However, the study’s limitations include its small sample size (n = 29) and its single-centric design. Even though this may limit generalizability, it ensures consistency, reducing potential confounders that might arise in multicenter studies with varying protocols.

Optilait was associated with improvements in weight gain, head circumference, and height among neonates requiring formula supplementation, along with a high level of compliance throughout the study period. The observed growth changes were statistically significant and suggest that Optilait may provide nutritional support for infant growth and development in situations where supplementation is required. While mild adverse events were reported, they were manageable and did not appear to affect overall tolerability. Overall, these findings suggest that Optilait may be a well-tolerated formula option for infants who require nutritional supplementation.

The authors declare that this study was supported by Shalina Healthcare, which was involved in product supply (Optilait®), study conduct, data analysis, and manuscript preparation, which involves final draft review and inputs wherever required.