Trial reportTrials2013
An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks' gestation: results of the TIPIT trial.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Subarachnoid space in infancy and early childhood: a systematic review of measurements.Pediatric radiology · 2026Pooled it
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Neurodevelopmental Outcomes at 42 Months After Thyroxine Supplementation in Infants Below 28 Weeks' Gestation: A Randomized Controlled Trial.Thyroid : official journal of the American Thyroid Association · 2020Trial
- Effect of thyroxine on brain microstructure in extremely premature babies: magnetic resonance imaging findings in the TIPIT study.Pediatric radiology · 2014Trial
- Neurodevelopmental outcomes in children with transient hypothyroxinemia of prematurity assessed using the Denver Developmental Screening Test II (DDST-II).Archives of endocrinology and metabolism · 2026Observational
- An Overview on Different L-Thyroxine (l-TFrontiers in endocrinology · 2022Review
- Hyperoxia Leads to Transient Endocrine Alterations in the Neonatal Rat During Postnatal Development.Frontiers in pediatrics · 2021Article
- Guideline for the Treatment of Hypothyroidism in Prematurity.International journal of preventive medicine · 2021Review
- Thyroid Function in Preterm/Low Birth Weight Infants: Impact on Diagnosis and Management of Thyroid Dysfunction.Frontiers in endocrinology · 2021Review
- Cross-sectional study of drug utilisation in a Chinese neonatal unit.The Journal of international medical research · 2020Article
- Thyroxine Threshold Is Linked to Impaired Outcomes in Preterm Infants.Frontiers in pediatrics · 2020Article
- Treatment preference and recruitment to pediatric RCTs: A systematic review.Contemporary clinical trials communications · 2019Article
- Extreme Premature Small for Gestational Age Infants Have Appropriate Catch-up Growth at Term Equivalence Compared with Extreme Premature Appropriate for Gestational Age InfantsJournal of clinical research in pediatric endocrinology · 2019Article
- Ultrasound Measurements of Thyroid Gland Volume at 36 Weeks' Corrected Gestational Age in Extremely Preterm Infants Born before 28 Weeks' Gestation.European thyroid journal · 2018Article
- Transient hypothyroidism in the newborn: to treat or not to treat.Translational pediatrics · 2017Review
- Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct.British journal of clinical pharmacology · 2015Review
- Failure of thyroid hormone treatment to prevent inflammation-induced white matter injury in the immature brain.Brain, behavior, and immunity · 2014Article
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.
Funding
Abstract
backgroundBabies born before 28 weeks' gestation have lower plasma thyroid hormone concentrations than more mature infants. This may contribute to their risk of poor developmental outcome. Previous studies have suggested that thyroxine supplementation for extremely preterm neonates may be beneficial. The aim of this study was to investigate the effect of administration of supplemental thyroxine to very premature babies on brain size and somatic growth at 36 weeks' corrected gestational age (CGA).
methodsIn this explanatory multicentre double blind randomised placebo controlled trial, 153 infants born below 28 weeks' gestation were randomised to levothyroxine (LT4) supplementation or placebo until 32 weeks' CGA. The primary outcome was brain size assessed by the width of the subarachnoid space measured by cranial ultrasound at 36 weeks' CGA. Lower leg length was measured by knemometry.
resultsBabies in the LT4-supplemented and placebo groups had similar baseline characteristics. There were no significant differences between infants given LT4 (n=78) or placebo (n=75) for width of the subarachnoid space, head circumference at 36 weeks' CGA, body weight at 36 weeks' CGA or mortality. Infants who received LT4 had significantly shorter leg lengths at 36 weeks' CGA although adjusted analysis for baseline length did not find a statistical difference. There was a significant correlation between low FT4 and wider subarachnoid space. No unexpected serious adverse events were noted and incidence of adverse events did not differ between the two groups.
conclusionThis is the only randomised controlled trial of thyroxine supplementation targeting extremely premature infants. Supplementing all babies below 28 weeks' gestation with LT4 had no apparent effect on brain size. These results do not support routine supplementation with LT4 for all babies born below 28 weeks' gestation.
trial registrationCurrent Controlled Trials ISRCTN89493983EUDRACT number: 2005-003-09939.
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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.