Article Text
Abstract
Objective To investigate the effect of Bifidobacterium bifidum OLB6378 on the development of very low birthweight (VLBW) infants at 18 months of corrected age.
Design Long-term follow-up study of a cluster-randomised, placebo-controlled trial.
Patients VLBW infants (birth weight <1500 g) born between January 2010 and March 2011 and managed at 19 neonatal intensive care unit facilities assigned to two groups to account for the effect of probiotic cross-contamination within facilities.
Interventions For VLBW infants, administration of OLB6378 as a probiotic was started within 48 hours of birth and continued until the body weight reached 2000 g.
Main outcome measures At 18 months of corrected age, physical status and developmental quotient (DQ18) were assessed. The distribution of DQ18 scores was categorised into four levels of development: <70, significant developmental delay; 70–84, moderate developmental delay; 85–99, without developmental delay; ≥100, average development or better.
Results Among 153 infants assigned to the OLB6378 administration group and 130 assigned to the placebo administration group, 102 and 105 infants, respectively, underwent the 18-month medical examination. The distribution of developmental levels (DQ18 scores <70, 70–84, 85–99 and ≥100) was significantly more favourable for OLB6378 administration (12, 12, 25 and 40 infants, respectively) than for placebo administration (15, 17, 23 and 24 infants, respectively) (ordered logistic regression analysis: partial correlation coefficient, 0.589; P value, 0.038).
Conclusions Although limited by assessment rates, result suggests that OLB6378 may have a beneficial effect on the psychological development in VLBW infants.
Clinical trial registration UMIN000002543.
- bifidobacterium
- developmental quotient at 18 months of age
- enteral feeding
- sex difference
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Footnotes
Contributors ST, the corresponding author, had a major role in study design, data analysis, drafted the initial manuscript and takes final responsibility for the decision to submit for publication. MT was involved in running the trial, reviewed the manuscript and approved the final manuscript as submitted. SK also had a major role in study design, data collection, interpretation of results and approved the final manuscript as submitted.
Funding This study was partially funded by the Food Science Institute Foundation, Japan. The interventions for this trial were provided by Meiji Co, Ltd. (Tokyo, Japan).
Competing interests MT is employed by Meiji Co., Ltd.
Patient consent Parental/guardian consent obtained.
Ethics approval The study protocol and follow-up analysis were approved by the Ethics Committee of the Tokyo Women’s Medical University (registration number 1675).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All the data in the study are available to researchers via a data request to the corresponding author.
Collaborators Staff in Recruiting Hospitals Iwate Medical University, Morioka: Takeo Kasai; Japanese Red Cross Akita Hospital, Akita: Hirokazu Arai; Fukushima Medical University, Fukushima: Maki Sato; Fukushima National Hospital, Kohriyama: Niro Ujiie, Tsutomu Kawahara, Tsutomu Isii; Ibaraki Children’s Hospital, Mito: Junichi Arai; Shinshi University, Mashumoto: Atsushi Baba; Niigata Prefectural Central Hospital, Takada: Kinuko Kojima; Nagaoka Red Cross Hospital, Nagoya: Junya Onozuka; Takaoka Hospital, Toyama: Hiroaki Imamura; Gifu Prefecture General Medical Hospital, Gifu: Yoshinori Kono; Shizuoka Saiseikai General Hospital, Shizuoka: Takahiro Sugiura; Nagoya City West Medical Center, Nagoya: Sumio Fukuda; Shiga University of Medical Science, Otsu: Takahide Yanagi, Sayuri Nakahara; Uji-Tokusyukai Medical Center, Uji: Shinichiro Tanaka, Hitoshi Awakuni; Shimane Prefectural Central Hospital, Shimane: Fumihide Kato; Kurashiki Central Hospital, Kurashiki: Shinichi Watabe, Akihito Takahashi; Tsuyama Cyuo Hospital, Tsuyama: Moriharu Sugimoto; Kawasaki Medical School, Okayama: Yutaka Kawamoto; National Hospital Organization Nagasaki Medical Center, Omura: Mikihiro Aoki.