BackgroundInfant feeding regimens, including breastfeeding, formula-feeding, or a combination of the two, may influence infant health-related quality of life (HRQOL). However, few studies have examined this association.MethodsThis prospective cohort study assessed HRQOL in relation to three parent-selected feeding regimens: exclusively breastfed (n = 136), exclusively study formula-fed (n = 140), and mixed-fed with study formula and breast milk (n = 151). Healthy Chinese infants were enrolled at their first normally scheduled well infant clinic visit at age 42 days (study day 1). Parents independently chose their infants’ feeding regimens prior to recruitment into the study, with infants in the formula and mixed-fed groups already consuming an infant formula enriched with α-lactalbumin and increased sn-2 palmitate and oligofructose. The Infant and Toddler Quality of Life Questionnaire, which includes six infant-focused and three parent-focused concepts, was used to assess HRQOL at day 1 and at a follow-up visit 48 days later. Scores for each concept ranged from 0 to 100. Parent quality of life (assessed using the Mental Component Summary score of the SF-12v2 Health Survey) was included in the ANCOVA model to adjust for its potential effect on parent’s perception of infant HRQOL.ResultsHRQOL concept scores were high in all three study groups at both visits (mean scores 71–95). Day 1 HRQOL scores were not significantly different between groups. At day 48, 5 of 9 HRQOL scores were not significantly different between groups. However, scores for Temperament and Moods, General Health Perceptions and Parent Impact–Time were slightly but statistically significantly lower in the formula-fed group (mean scores 75–86; all p ≤ 0.01) compared to the breastfed (78–90) and mixed-fed (77–91) groups. Day 48 Parent Impact–Emotional scores were also significantly lower by a small margin (4 points; p = 0.003) in the formula-fed group compared with the breastfed group.ConclusionsHRQOL was high in this population of healthy infants, with only a few small differences in HRQOL concept scores observed between breastfed, formula-fed and mixed-fed infants. These results indicate favorable physical, mental, and social well-being in these infants and parents. Assessment of infant HRQOL is therefore feasible and provides valuable insight into parental perceptions of their child’s health and well-being.Trial registrationClinicalTrials.gov, NCT01370967.
To study feeding tolerance in infants fed formula with increased sn-2 palmitate and oligofructose (sn-2+OF) in a real-world setting, healthy Chinese infants were enrolled in this 48-day observational study on their current feeding regimens: exclusively breastfed (BF; n = 147), exclusively sn-2+OF formula-fed (FF; n = 150), or mixed-fed with breast milk and sn-2+OF formula (MF; n = 163). Throughout the study, incidence (90% confidence interval) of hard stools was ≤2.1% (0.0-5.3) in FF and 0.8% (0.0-3.5) in MF, with no hard stools in BF. Incidence of watery stools was ≤5.0% (1.0-9.2) in FF and ≥5.1% (2.4-9.3) in MF and BF. Gastrointestinal tolerance scores, although low in all groups (lower scores indicating better tolerance), were slightly higher (P ≥ .03) in FF (17.5 ± 4.8) and MF (18.2 ± 5.0) versus BF (16.3 ± 3.2) at mid-study; this difference disappeared at study end. Overall, low incidences of hard and watery stools and good feeding tolerance were observed in infants fed sn-2+OF formula.
Objective Evaluate the feasibility and psychometric properties of the Infant Toddler Quality of Life (ITQOL) questionnaire as a measure of health-related quality of life (HRQOL) in a sample of Chinese infants. Methods The linguistically validated Simplified Chinese version of the ITQOL was used in a multicenter, observational study of healthy, term infants (N = 427), age 6 weeks at enrollment, in China. At Days 1 and 48, parents/guardians completed the ITQOL, the Short Form Health Survey (SF-12v2) and the Infant Gastrointestinal Symptom Questionnaire (IGSQ). ITQOL feasibility, reliability, ceiling/floor effects, concurrent validity and discriminatory validity were evaluated. Results Feasibility of administering the ITQOL was supported by strong response rates (> 97%) with < 1% missing items for all scales except physical abilities. Reliability was acceptable (Cronbach’s alpha > 0.70) for all scales except Day 1 General Health (0.67). Floor effects were minimal (< 2%), except Day 1 physical abilities (7%). Ceiling effects increased from Days 1 to 48 across all scales. Concurrent validity was demonstrated by correlations between ITQOL infant-focused scales and IGSQ score (r = −0.20 to − 0.34, p < 0.001) and between parent-focused scales and SF-12v2 mental health composite (MCS) scores (r = 0.29–0.46, p < 0.001). ITQOL scales discriminated between infant subgroups based on illness-related outcomes (sick visits, adverse events) and between parent subgroups based on SF-12v2 MCS scores. Conclusion The Simplified Chinese version of the ITQOL performed well in a community-based sample of Chinese infants, with evidence supporting the instrument’s feasibility, reliability, and validity. These data support the ITQOL as a valuable tool to assess HRQOL in Chinese infants.
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