Preterm birth and low birth weight (LBW) remain major contributors to neonatal mortality and long-term morbidity worldwide. In 2020, an estimated 13.4 million infants were born preterm, accounting for approximately 10% of all live births globally. India has the highest absolute burden of preterm births, with an estimated 3.02 million preterm births reported during the same period.(1) Preterm and small-for-gestational-age (SGA) infants together contribute to more than 80% of neonatal deaths, with complications related to prematurity, including necrotizing enterocolitis (NEC) and feeding intolerance, accounting for a substantial proportion of these deaths. Gavage feeding is commonly required in preterm infants because of their immature suck-swallow-breathe coordination. However, gastrointestinal immaturity and impaired gut motility can predispose these infants to delayed gastric emptying, feeding intolerance, regurgitation, NEC, sepsis, and delayed progression to full oral feeding.(2-5) Kangaroo Mother Care (KMC) is a simple, low-cost and high-impact intervention that has demonstrated several beneficial effects in preterm and LBW infants, including improved thermoregulation, stabilization of vital parameters, reduction in physiological stress, enhanced maternal milk production, and improved mother–infant bonding.(6-9) Despite the well-established benefits of KMC, evidence regarding its specific effect when administered concurrently with gavage feeding remains limited, particularly in the Indian setting. The present study was therefore undertaken to systematically evaluate the effect of KMC during gavage feeding in preterm infants, with particular emphasis on feeding tolerance, weight gain, progression from enteral to oral feeding, NEC, associated morbidities, and duration of hospitalization. AIM AND OBJECTIVES AIM To evaluate the effect of Kangaroo Mother Care during gavage feeding in preterm low birth weight infants. PRIMARY OBJECTIVES To determine the effect of Kangaroo Mother Care during gavage feeding on: 1. Weight gain. 2. Feeding intolerance. 3. Incidence of necrotizing enterocolitis in preterm infants. SECONDARY OBJECTIVES To evaluate the effect of Kangaroo Mother Care during gavage feeding on: 1. Duration of hospital stay. 2. Incidence of associated morbidities, including sepsis. 3. Neonatal mortality. DATA COLLECTION AND STATISTICAL ANALYSIS Demographic, clinical, and feeding-related parameters were prospectively recorded for all enrolled infants. Outcome assessment was performed by assessors who were blinded to group allocation wherever feasible. Statistical analysis was carried out using SPSS version 23. Continuous variables were analyzed using appropriate t-tests, while categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate. A p-value of <0.05 was considered statistically significant.

STUDY DESIGN AND SETTING This randomized controlled trial was conducted in the Department of Neonatology at a tertiary care centre in NORTHERN India. ETHICAL CLEARANCE AND CONSENT The study received approval from the Institutional Ethics Committee before commencement. Written informed consent was obtained from the parents or legal guardians of all eligible neonates after providing a detailed explanation of the study procedures in the local language (Hindi). PARTICIPANTS INCLUSION CRITERIA Hemodynamically stable preterm neonates with birth weight [as per the predefined study eligibility criteria]. EXCLUSION CRITERIA Neonates were excluded if they had any of the following: 1. Major congenital malformations. 2. Hemodynamic instability. 3. Perinatal asphyxia with HIE grade II or III. 4. Grade II or III intraventricular hemorrhage. 5. Requirement for any surgical intervention. SAMPLE SIZE The sample size for this randomized controlled trial was calculated using the formula for comparison of two means, based on the findings of the study by Yalnızoğlu Çaka et al. (2023).(10) Considering a confidence level of 95% and a statistical power of 90%, the minimum required sample size was estimated to be 45 participants in each group. After accounting for a potential 10% dropout rate, the estimated sample size was approximately 100 participants. To increase the statistical power and improve the precision of the study estimates, a total of 124 neonates were ultimately enrolled, with 62 participants allocated to each group. RANDOMIZATION AND INTERVENTION PROTOCOL Following Institutional Ethics Committee approval and informed consent, eligible neonates were randomly assigned to one of two study groups using computer-generated block randomization. Allocation concealment was maintained using serially numbered opaque sealed envelopes (SNOSE). Due to the nature of the intervention, blinding of mothers and caregivers was not feasible. However, personnel responsible for intervention delivery were kept separate from those involved in outcome assessment and data analysis, wherever possible, to minimize the risk of assessment bias. Group 1: Gavage Feeding During Kangaroo Mother Care (GF-KMC). Infants allocated to the intervention group received gavage feeding while being maintained in the Kangaroo Mother Care position. KMC was continued for the maximum duration feasible within a 24-hour period, depending on maternal comfort and availability, with a minimum target duration of 5 hours per day. Group 2: Gavage Feeding in Supine Position (GF-S) Infants in the control group received gavage feeding in the conventional supine position and continued to receive standard routine neonatal care as per institutional protocol.

Table 1- Comparison of Baseline Parameters in Conventional Newborn Care with Gavage Feeding vs Kangaroo Mother Care on Gavage Feeding. Variables (n=124) (Mean ± SD) Conventional Newborn Care with Gavage Feeding (n=62) Kangaroo Mother Care (n=62) P Value Birth Weight (Grams) 1570.08 ± 172.16 1604.44 ± 151.70 0.162** Gestational Age in Weeks 33.55 ± 1.68 34.04 ± 1.61 0.106** APGAR Score at 1 Min 5.55 ± 0.62 5.75 ± 0.49 0.065** APGAR Score at 5 Min 7.44 ± 0.62 7.76 ± 0.34 0.071** HR Before Feed (Min) 146.54 ± 5.80 146.16 ± 5.89 0.677** RR Before Feed (Min) 47.75 ± 3.08 48.01 ± 3.27 0.083** SPO2 Before Feed (%) 97.32 ± 0.97 98.02 ± 0.99 0.123** Gender Female n (%) 33 34 0.866 Male n (%) 29 28 Mode of Delivery LSCS n (%) 50 48 0.664 NVD n (%) 12 14 SD: Standard Deviation, **: Mann Whitney U test, n: Numbers, %: Percentage, !: Pearson’s Chi Square test. Table 2- Comparison of feeding parameters in Conventional Newborn Care on Gavage Feeding vs Kangaroo Mother Care on Gavage Feeding. Variables (n=124) (Mean ± SD) Conventional Newborn Care with Gavage Feeding (n=62) Kangaroo Mother Care (n=62) P Value Day of Initiation of Gavage Feed 2.35 ± 1.20 2.09 ± 1.14 0.199** Episodes of Feed Regurgitation 3.34 ± 1.43 2.14 ± 1.75 <0.002** Time of Transition of Full Enteral Feed 5.21 ± 2.94 3.78 ± 1.86 0.003** Day of Initiation of Oral Feed 7.33 ± 3.89 5.06 ± 2.34 0.004** Increase in AG>2 CM From Baseline n (%) 24 (38.7) 10 (16.0) 0.016** SD: Standard Deviation, **: Mann Whitney U test, !: Pearson’s Chi Square test. Table 2 presents a comparison of neonatal feeding parameters between the GF-S and GF-KMC groups. The mean day of initiation of gavage feeding was marginally earlier in the GF-KMC group (2.09 ± 1.14 days) than in the GF-S group (2.35 ± 1.20 days); however, the difference was not statistically significant (p=0.199). In contrast, significant differences were observed for several feeding outcomes. Infants in the GF-KMC group had significantly fewer episodes of feed regurgitation compared with those in the GF-S group (2.14 ± 1.75 vs. 3.34 ± 1.43; p<0.002). They also achieved full enteral feeding earlier (3.78 ± 1.86 vs. 5.21 ± 2.94 days; p=0.003) and initiated oral feeding at an earlier age (5.08 ± 2.34 vs. 7.35 ± 3.89 days; p=0.004). Abdominal distension was significantly more frequent among infants in the GF-S group than in the GF-KMC group (38.7% vs. 16.0%; p=0.016). Overall, these findings suggest that providing KMC during gavage feeding may improve feeding tolerance and facilitate earlier progression to full enteral and oral feeding in preterm infants. Table 3- Comparison of Average Weight Gain Per day (Grams) in Conventional Newborn Care on Gavage Feeding vs Kangaroo Mother Care on Gavage Feeding. Variables (n=124) (Mean ± SD) (Grams) Conventional Newborn Care with Gavage Feeding (n=62) Kangaroo Mother Care (n=62) P Value Average Weight Gain Per day 6.66 ± 1.03 9.77 ± 2.79 <0.002** Weight on Discharge 1545.59 ± 160.16 1623.48 ± 146.77 0.006** Weight on Day 21 1606.77 ± 183.85 1715.62 ± 167.91 0.002** SD: Standard Deviation, **: Mann Whitney U test. Table 2 compares the average daily weight gain, weight on day 21, and weight at discharge between the two study groups. The mean daily weight gain was significantly greater among infants in the GF-KMC group than in the GF-S group (9.77 ± 2.79 g vs. 6.66 ± 1.03 g; p<0.002). Similarly, the mean discharge weight was significantly higher in the GF-KMC group (1624.49 ± 146.77 g) compared with the GF-S group (1547.59 ± 160.16 g; p=0.006). The mean weight on day 21 was also significantly higher among infants receiving KMC during gavage feeding than those receiving conventional gavage feeding (1714.61 ± 167.91 g vs. 1605.78 ± 183.85 g; p=0.002). These findings demonstrate that KMC during gavage feeding was associated with greater and sustained weight gain among preterm infants. Table 4- Comparison of incidence of NEC and sepsis in Conventional Newborn Care with Gavage Feeding vs Kangaroo Mother Care on Gavage Feeding. Variables (n=124) Conventional Newborn Care with Gavage Feeding (n=62) Kangaroo Mother Care (n=62) P Value NEC Yes n (%) 8 (12.9) 8 (12.9) >0.988 No n (%) 54 (87.1) 54 (87.1) SEPSIS Yes n (%) 29 (46.7) 12 (19.3) 0.003 No n (%) 33 (54.3) 49 (80.7) n: Numbers, %: Percentage, !: Pearson’s Chi Square test. RESULTS Comparison of NEC and Sepsis Between the Study Groups Table 4 compares the incidence of necrotizing enterocolitis (NEC) and sepsis between the GF-S and GF-KMC groups. NEC occurred in 8 infants (12.9%), while 54 infants (87.1%) did not develop NEC. There was no statistically significant difference in the incidence of NEC between the two groups (p>0.988), suggesting that KMC during gavage feeding did not significantly alter the occurrence of NEC compared with conventional gavage feeding. In contrast, a significant difference was observed in the incidence of sepsis. Sepsis developed in 29 infants (46.7%) in the GF-S group compared with 12 infants (19.3%) in the GF-KMC group. This difference was statistically significant (p=0.003), indicating a lower incidence of sepsis among infants who received KMC during gavage feeding.

This randomized controlled trial evaluated the effect of Kangaroo Mother Care during gavage feeding on feeding tolerance, weight gain, NEC, and other clinical outcomes in preterm neonates. The findings demonstrated significantly improved feeding tolerance among infants receiving KMC during gavage feeding. Infants in the KMC group experienced fewer episodes of feed regurgitation (p<0.002), less abdominal distension (p=0.026), and lower volumes of regurgitated feeds (p=0.028), suggesting improved gastrointestinal tolerance and coordination. The physiological effects of KMC, including enhanced parasympathetic activity, may contribute to improved gastrointestinal motility and digestion.(14,15,17) Furthermore, infants receiving KMC achieved full enteral feeding (p=0.003) and initiated oral feeding (p=0.004) earlier than those in the control group. This may reflect improved physiological stability and maturation of feeding-related functions.(12,16) These findings are consistent with observations reported by Suman et al. (2008) and Hake-Brooks & Anderson (2008), who also demonstrated beneficial effects of KMC on feeding-related outcomes.(19,20) A significantly greater rate of weight gain was observed in the KMC group (p<0.002), with significantly higher weights at discharge and on day 21 (p=0.006 and p=0.002, respectively). These differences were observed despite comparable feeding protocols between the groups, suggesting that the physiological effects associated with KMC may have contributed to improved growth. Improved thermoregulation, modulation of hormonal responses, reduced physiological stress, and improved energy conservation are possible mechanisms underlying these findings. Similar beneficial effects of KMC on growth have been reported by Conde-Agudelo & Díaz-Rossello,(15) Charpak et al.,(16) and Boundy et al.(12) KMC was also associated with a significantly lower incidence of neonatal sepsis (p=0.003), although no significant difference was observed in the incidence of NEC. The reduction in infection may potentially be related to improved immune function, exposure to maternal microbial flora, enhanced breastfeeding-related protection, and reduced unnecessary handling of the infant.(14,15,16) Similar reductions in neonatal infection associated with KMC have been reported by Mazumder et al.(18) and Boundy et al.(12,41) Although the incidence of NEC did not differ significantly between the two groups, the improved feeding tolerance and gastrointestinal parameters observed in the KMC group may indicate potential beneficial effects on gut function. However, given the multifactorial pathogenesis of NEC, these findings should be interpreted cautiously.(26-31) The KMC group also demonstrated significantly lower mortality (p=0.047) and a shorter duration of hospital stay (p=0.002). These findings may be related to the overall improvement in physiological stability, feeding progression, growth, and reduced infection observed with KMC. Similar benefits of KMC on neonatal outcomes have been reported in WHO reviews(11) and by Tessier et al.(22,32) An important observation in this study was the apparent association between the duration of KMC and neonatal outcomes. Infants who received KMC for 9–12 hours per day demonstrated significantly better outcomes, including greater discharge weight (p<0.002), earlier initiation of feeding (p=0.003), fewer episodes of regurgitation (p<0.002), and lower incidence of NEC (p=0.035). No cases of NEC were observed among infants receiving 9–12 hours of KMC daily, whereas NEC occurred in 19.3% of those receiving 5–8 hours per day. These findings suggest a possible dose-response relationship between the duration of KMC and neonatal outcomes. Similar observations regarding the benefits of prolonged KMC have been reported by Surandran & Nagendra (2023),(23) Gagandeep et al. (2019),(24) and Conde-Agudelo & Díaz-Rossello.(25,33) Overall, the findings of this study suggest that prolonged KMC during the gavage-feeding period may have beneficial effects on feeding tolerance, growth, infection-related outcomes, and survival in preterm infants. Incorporating extended KMC into routine NICU care may therefore provide an accessible and potentially cost-effective strategy, particularly in resource-limited settings.(34-40) LIMITATIONS Single-Centre Study: The study was conducted at a single tertiary-care centre, which may limit the generalizability of the findings to other neonatal units and healthcare settings. Short-Term Outcome Assessment The study primarily evaluated short-term neonatal outcomes. Long-term effects of KMC during gavage feeding on growth, neurodevelopment, and feeding outcomes were not assessed. Lack of Blinding Blinding of caregivers and mothers was not possible because of the nature of the KMC intervention, which may have introduced performance or observer-related bias. Potential Uncontrolled Confounding Despite randomization, other factors that could influence feeding tolerance, growth, infection, and hospitalization may not have been completely controlled.

Kangaroo Mother Care administered during gavage feeding was associated with improved feeding tolerance, greater weight gain, reduced duration of hospital stay, and lower mortality among preterm infants. Although the overall incidence of NEC did not differ significantly between the study groups, prolonged KMC was associated with more favorable feeding and growth outcomes and a lower observed incidence of NEC. The findings also suggest that longer daily exposure to KMC during the gavage-feeding period may provide additional benefits. KMC should therefore be considered an important component of supportive care for preterm and LBW infants during the transition to full enteral and oral feeding. WHAT IS ALREADY KNOWN? Kangaroo Mother Care is a safe, feasible, low-cost intervention with established physiological and clinical benefits for preterm and low-birth-weight infants. Its use during gavage feeding is also feasible and may contribute to improved physiological stability and feeding-related outcomes. WHAT DOES THIS STUDY ADD? This study demonstrates that providing gavage feeding during KMC is associated with improved feeding tolerance, earlier progression to full enteral and oral feeding, greater weight gain, shorter hospital stay, and lower mortality among preterm infants. The study also highlights the potential importance of prolonged KMC exposure during the gavage-feeding period, with infants receiving longer durations of KMC demonstrating more favorable clinical outcomes. These findings support the integration and promotion of KMC during gavage feeding as part of routine care for preterm and LBW infants.

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