The Association of Hormones and Peptides With Nutritional Consequences in Children With Feeding Difficulty.
Condition: Feeding Difficulty
Study type: Observational

Summary: 
      To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1,
      IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in
      children with feeding difficulty, and further to evaluate their regulation with feeding
      difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical
      conditions).
    

Detailed description: 
      The investigations plan to prospectively evaluate the plasma concentration of endocrine
      parameters in children with feeding difficulties. The studied children are arranged to do the
      dietary records, clinical survey and laboratory studies at the inpatient or outpatient
      department at clinical evaluation and follow-up. The duration of evaluation and follow-up is
      3 months. The healthy children in the control group are also assigned to do the dietary
      records, clinical survey and laboratory studies after exclusion of feeding difficulty and
      malnutrition by feeding and nutritional assessment (same survey as the studied patients
      demonstrated in the following section "clinical survey"). The healthy children do not need
      the follow-up assessment at 12 weeks.

      The diagnosis of feeding difficulty is based on "IMFeD" program. The categorizations of
      feeding difficulties in the IMFeD tool was originally developed by Dr. Chatoor and Dr.
      Kerzner (Clinical investigation of feeding difficulties in young children: a practical
      approach, Clinical Pediatrics, 2009). The 7-day dietary records and assessment of daily
      calories are evaluated by dietician and research assistant. Nutritional assessment includes
      7-day dietary record, assessment of daily calories, body weight (BW), body height (BH),
      weight for age z-score, height for age z-score, BMI, BMI for age z-score, weight for height
      index, weight-for-height z-score, severity of malnutrition, and nutritional serum markers
      (hemoglobin, lymphocyte count, pre-albumin, albumin, ferritin, and zinc). Growth standards
      for height, weight, and BMI based on World Health Organization (WHO) population were used to
      obtain z-scores for each measurement, according to age and gender. The severity of
      malnutrition is determined by weight-for-height.

      The laboratory studies will be performed at baseline and at 12 weeks. Venous blood is
      collected in Serum separation tubes and kept at 4 °C for 1 before being centrifuged, and the
      serum is stored at -80 °C. All measurements are performed in the same assay without
      extraction. Concentrations of serum ghrelin, leptin, adiponectin, NPY, orexin A, IGF-1,
      IGFBP-1, IGFBP-3 and CRH are all determined using enzyme-linked immunosorbent assay (ELISA)
      kits. All assays were performed according to the manufacturers' instructions.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. Studied subjects: children with clinical diagnosis of feeding difficulty.

          2. Methods of study: A total of 90 children aged 2-12 years old with feeding difficulty
             are enrolled into the study, and 30 healthy children are used as control. The enrolled
             subjects with feeding difficulty are assigned clinical survey for 12 weeks and
             laboratory studies at enrollment and at 12 weeks, and they are classified into 3
             groups: (1) Group 1: 30 patients without malnutrition, (2) Group 2: 30 patients with
             mild malnutrition, and (3) Group 3: 30 patients with marked malnutrition.
      
Biospecimen description: 
      Venous blood is collected in Serum separation tubes and kept at 4 °C for 1 before being
      centrifuged, and the serum is stored at -80 °C.