Trial reportPaediatric drugs2014
A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial.
Trial report in Paediatric drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01940068 (A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates), which is not on this map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Who cites it
6 citing papers in PubMed, 18 citations in OpenAlex.
- A well-tolerated new amino acid-based formula for cow's milk allergy.Immunity, inflammation and disease · 2020Trial
- Budget Impact of Early Introduction of Amino Acid Formula in Managing Infants with Cow Milk Protein Allergy: Arabian Gulf Countries' Experience.Journal of asthma and allergy · 2023Article
- The use of amino acid formulas in pediatric patients with allergy to cow's milk proteins: Recommendations from a group of experts.Frontiers in pediatrics · 2023Review
- Re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives.EFSA journal. European Food Safety Authority · 2017Article
- Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula.Journal of pediatric gastroenterology and nutrition · 2016Observational
- Improved Impact on Clinical Outcomes and Reduced Cost of Care Associated With Switching Hypoallergenic Amino Acid-Based Formulas.Sage open pediatricsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAmino-acid-based formulas (AAFs) are recommended for children with cow's milk protein allergy (CMPA) failing to respond to extensively hydrolyzed formulas (eHFs).
objectiveThis study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF (TAAF) in these infants.
methodsThis multicenter, double-blind, randomized controlled trial (NCT01940068) compared 3-month feeding with a pectin-based TAAF (Novalac(®), United Pharmaceuticals, Paris, France) and a commercially available "reference" AAF (RAAF; Neocate(®), Nutricia, Germany) in infants aged <18 months with CMPA and persistent allergy symptoms with eHF feeding. Reported here are the results of an interim analysis after 1 month of feeding.
resultsOf the 86 infants randomized, CMPA with eHF intolerance was confirmed in 75 infants; all of them tolerated the allocated AAFs. The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF, respectively. Infants had significantly more normal stools (soft or formed consistency) with the TAAF (90.5 vs. 66.7 %; p = 0.011). From baseline, daily family life significantly improved with both AAFs: crying time decreased by 97.3 (p < 0.001) and 28.6 min (p = 0.014) and sleeping time increased by 64.6 (p = 0.009) and 29.0 min with TAAF and RAAF, respectively. At day 30, weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF.
conclusionBoth AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.