Table 3.
Overview of ongoing or recently completed trials investigating the effect of a supplemental enteral bioactive factor in preterm infants.
| Intervention Group | Control Group | Intervention Duration | Estimated Number of Participants | Main Inclusion Criteria | Country | Year of Registration | Trial Registry | Trial Registry Identifier |
|---|---|---|---|---|---|---|---|---|
| Hormones and growth factors | ||||||||
| Insulin (400 µU/mL milk) | Placebo | 28 days | 33 | GA 26–33 weeks | Israel | 2010 | ClinicalTrials.gov | NCT01093638 |
| Insulin (low-dose group: 400 µU/mL milk, high-dose group: 2000 µU/mL milk) | Placebo | 28 days | 530 | GA 26–32 weeks and BW ≥ 500 g | Belgium, Bulgaria, France, Germany, Hungary, Israel, Italy, The Netherlands, Spain, United Kingdom, United States | 2015 | ClinicalTrials.gov, EU Clinical Trials Register | NCT02510560, 2014-002624-28 |
| RhEPO (88 IU/kg/day) | Placebo | Until an enteral intake of 150 mL/kg/day or for a maximum of 10 days | 72 | GA < 32 weeks | Egypt | 2018 | Pan African Clinical Trial Registry | PACTR201806003426116 |
| Melatonin (3 mg/kg/day) | Placebo | 15 days | 60 | GA < 29 + 6 weeks, able to receive minimal 20 mL/kg/day enteral nutrition within 96 h from birth | Italy | 2020 | ClinicalTrials.gov | NCT04235673 |
| Melatonin (20 mg) | Standard care | Once | 90 | GA < 37 weeks, evidence of feeding intolerance | Egypt | 2020 | ClinicalTrials.gov | NCT04304807 |
| Vitamins | ||||||||
| Vitamin A (5000 IU/kg/day) | Placebo | 28 days | 914 | GA < 32 weeks, BW < 1000 g, < 72 h of age, oxygen supplementation or respiratory support in the first 72 h of life | Germany, Austria | 2014 | EU Clinical Trials Register, German Clinical Trials Register | 2013-001998-24, DRKS00006541 |
| Vitamin A (30,000 IU/kg/day) [45] | Standard care | 6 weeks | 209 | GA ≤ 32 weeks and BW ≤ 1250 g, FiO2 > 21% within the first 24 h of life | Turkey | 2014 | Conference abstract in Archives of Disease in Childhood | P0-0731 |
| Vitamin A (5000 IU/day) [46] | Placebo | Start: within 24 h of initiation of enteral feeding, duration: until 34 weeks’ PMA | 188 | GA < 28 weeks and <72 h of life | Australia | 2016 | Australian New Zealand Clinical Trials Registry | ACTRN12616000408482 |
| Vitamin A (2000 IU/day) and vitamin D (700 IU/day) | Standard care | 28 days | 976 | GA < 32 weeks, <96 h of age | China | 2018 | ClinicalTrials.gov | NCT03779776 |
| Vitamin E (12.5 IU every 12 h) | Placebo | Start: 72 h of life, duration: until day 28 postpartum | 90 | BW < 1500 g, diagnosed with RDS, mechanical ventilation or CPAP | Mexico | 2017 | ClinicalTrials.gov | NCT03274596 |
| Carotenoids | ||||||||
| Lutein (0.5 mg/kg/day) and zeaxantin (0.05 mg/kg/day) | Placebo | Start: <36 h of life, duration: until day 30 postpartum | 50 | GA ≤ 32 weeks and/or BW ≤ 1500 g | Italy | 2017 | ClinicalTrials.gov | NCT03340103 |
| Trace elements | ||||||||
| Zinc (1.4 mg/kg/day) | Standard care | 10 days | 180 | Preterm infants with sepsis | Egypt | 2020 | Thai Clinical Trials Registry | TCTR20200624002 |
| Zinc (10 mg/day) | Standard care | Until discharge | 120 | GA 28–37 weeks with sepsis | India | 2017 | Clinical Trials Registry India | CTRI/2017/08/009544 |
| Zinc acetate (2 mg/kg/day) | Standard care | Through 36 + 6/7 weeks PMA | 126 | GA 23–30 weeks, BW 501–1000 g, 14–28 days of life, 14-day BPD risk score ≥50% for death or moderate-severe BPD | United States | 2018 | ClinicalTrials.gov | NCT03532555 |
| Zinc (10 mg/day) | Placebo | Start: day 3 postpartum, duration: 40 weeks PMA or discharge, whichever comes first | 364 | GA 28–32 weeks | Indonesia | 2019 | ClinicalTrials.gov | NCT04050488 |
GA: gestational age, BW: birth weight, PMA: postmenstrual age, BPD: bronchopulmonary dysplasia.