Abstract The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) tested the hypothesis whether extensively hydrolyzed casein‐based versus regular cow's milk‐based infant formula reduces the risk of type 1 diabetes. We describe dietary compliance in the trial in terms of study formula intake, feeding of nonrecommended foods, and serum cow's milk antibody concentration reflecting intake of cow's milk protein among 2,159 eligible newborn infants with a biological first‐degree relative affected by type 1 diabetes and with HLA‐conferred susceptibility to type 1 diabetes. The participating infants were introduced to the study formula feeding at the median age of 15 days with a median duration of study formula use of 63 days. During the intervention, 80% of the infants received study formula. Of these, 57% received study formula for at least 2 months. On average, 45.5 l of study formula were used per infant. Only 13% of the population had received a nonrecommended food by the age of 6 months. The dietary compliance was similar in the intervention and control arm. The reported cow's milk consumption by the families matched very well with measured serum casein IgA and IgG antibody concentration. To conclude, good compliance was observed in this randomized infant feeding trial. Compliance varied between the regions and those infants who were breastfed for a longer period of time had a shorter exposure to the study formula. High dietary compliance in infant feeding trial is necessary to allow accurate interpretation of study results.

IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. INTERVENTIONS The participants received either a casein hydrolysate or a conventional adapted cow's milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. MAIN OUTCOMES AND MEASURES Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). RESULTS Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8%[95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). CONCLUSIONS AND RELEVANCE Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes.

Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines.

Objective: To examine the use of vitamin D supplements during infancy among the participants in an international infant feeding trial.Design: Longitudinal study.Setting: Information about vitamin D supplementation was collected through a validated FFQ at the age of 2 weeks and monthly between the ages of 1 month and 6 months.Subjects: Infants (n 2159) with a biological family member affected by type 1 diabetes and with increased human leucocyte antigen-conferred susceptibility to type 1 diabetes from twelve European countries, the USA, Canada and Australia.Results: Daily use of vitamin D supplements was common during the first 6 months of life in Northern and Central Europe (. 80% of the infants), with somewhat lower rates observed in Southern Europe (. 60 %). In Canada, vitamin D supplementation was more common among exclusively breast-fed than other infants (e. g. 71% v. 44% at 6 months of age). Less than 2% of infants in the USA and Australia received any vitamin D supplementation. Higher gestational age, older maternal age and longer maternal education were study-wide associated with greater use of vitamin D supplements.Conclusions: Most of the infants received vitamin D supplements during the first 6 months of life in the European countries, whereas in Canada only half and in the USA and Australia very few were given supplementation.

Background Both the initiation and maintenance of breastfeeding have been reported to be negatively affected by maternal type 1 diabetes (T1D). The aim of this study was to prospectively examine the breastfeeding patterns among mothers with and without T1D participating in a large international randomized infant feeding trial (TRIGR).Methods Families with a member affected by T1D and with a newborn infant were invited into the study. Those who had HLA-conferred genetic susceptibility for T1D tested at birth with gestation >35 weeks and were healthy were eligible to continue in the trial. Among the 2160 participating children, 1096 were born to women with T1D and 1064 to unaffected women. Information on infant feeding was acquired from the family by frequent prospective dietary interviews.Results Most (>90%) of the infants of mothers with and without T1D were initially breastfed. Breastfeeding rates declined more steeply among mothers with than without T1D being 50 and 72% at 6 months, respectively. Mothers with T1D were younger, less educated and delivered earlier and more often by caesarean section than other mothers (p < 0.01). After adjusting for all these factors associated with the termination of breastfeeding, there was no difference in the duration of breastfeeding among mothers with and without T1D.Conclusions Maternal diabetes status per se was not associated with shorter breastfeeding. The lower duration of breastfeeding in mothers with T1D is largely explained by their more frequent caesarean sections, earlier delivery and lower age and education. Copyright (C) 2010 John Wiley & Sons, Ltd.

Vaga vaikese sunnikaaluga enneaegsete elulemus ja tervisetulem on arenenud riikides viimasel kumnendil tunduvalt paranenud. Eestis puudusid seni andmed vaga enneaegsete laste tervise hilistulemi kohta. Uuritud 42-st alla 1500-grammise sunnikaaluga enneaegsest lapsest oli 3aastaselt terveid voi kergete, ravi mittevajavate funktsionaalsete korvalekalletega 61,9%. 1/6-l enneaegsetest esines uks voi mitu puuet. Enneaegsete laste koik kolm kasvumootu (kehakaal, pikkus ja peaumbermoot) olid 3aastaselt statistiliselt toeparaselt vaiksemad kui ajaliselt sundinud samavanustel lastel (p Eesti Arst 2009; 88(Lisa4):6−11

Artiklis on esitatud ulevaade vaga enneaegsete vastsundinute ravitrendidest maailmas ja Eesti Perinatoloogia Seltsi algatusel korraldatud uuringust, millest selgusid selle patsiendiruhma ravitulemused Eestis. Aastatel 2007–2008 hinnati internetipohise “Vastsundinute tervise andmekogu” baasil enneaegseid vastsundinuid ravitakse Eestis aktiivselt. Laste elulemus on korge ja varane haigestumine suur. Eesti Arst 2009; 88(Lisa4):12−20

We investigated the effect of early life nutrition on growth and intestinal microflora in low-birthweight infants. Eleven preterm newborns (birth weight 1456k293 g, gestational age 3O.6f 1.2 weeks) received special preterm infant formula as a sole diet from the first enteral feeding until the end of the second month of life (preterm infant formula group (PF group)). Thirteen infants (birth weight 1728k276 g; gestational age 32.6f1.4 weeks) received standard casein-dominant infant formulas available in Estonia (standard formula group (SF group)). Growth parameters were measured at the age of 1,2,3,4 weeks and 2 months. Faecal samples for short chain fatty acids (SCFAs) and bacterial cultures were collected at the age of 6 days and 2 months. Two results have been received: better growth and better microbial colonization in the group of preterm infant formula. There was significantly higher weight gain in the PF group at the age of 2 months (1 814f 566 g) than in the SF group (1255k365 g). The relative amount of coagulase negative staphylococci was significantly higher in the SF group at the age of 6 days in comparison with the PF group. At the age of 6 days the prevalence of faecal acetic acid was 98% of total concentration of short chain fatty acids in the PF group and 87% in the SF group (p<0.05), which shows the higher prevalence of anaerobic microbes in the PF group. Thus, a nutrient-enriched preterm formula has a positive effect on the intestinal bacterial colonization and growth of low-birth-weight infants.