VLBW infants (< 1,500 g), enrolled before day 10 of life.See (5) Additional information throughout.
Conditions
Interventions
Subjects will receive either the investigational drug or the standard diet for a maximum of 34 weeks 0 days of gestation. For the investigational drug group at 34 weeks day 1 a subject should take at
Sponsors
Kato Yoshio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.VLBW infants (<1,500 g) born before 31 weeks 0 days gestational age 2.Within the first 10 days of life (day 0-10) 3.Diet consisted of 100% exclusive HM (MOM or DM) or NPO prior to study enrollment 4.Willing to follow the study diet and adhere to study procedures per the legal guardian 5.Written informed consent from the legal guardian of the infant 6.Informed consent obtained prior to reaching 50 ml/kg/day because this is when fortification begins
Exclusion criteria
Exclusion criteria: 1.Lethal or otherwise significant congenital abnormalities known at the time of inclusion 2.Chromosomal anomalies known at the time of inclusion 3.Known gastrointestinal malformation at the time of inclusion 4.Participation in another intervention trial aiming at having an effect on growth, nutrition, feeding intolerance, or severe complications such as NEC and sepsis in VLBW infants, however it is permissible to participate in the interventional clinical trial of DM that is currently being run in Japan in parallel with this trial. 5.The subject is unable to start enteral feeding within the first 3 days of life and parenteral feeding within the first 2 days of life 6.Infants who, for medical reasons, cannot receive a feeding volume of at least 130 ml/kg/day 7.In the opinion of the investigator, the subject is incapable of receiving IMP and standard nutritional management. This may be due to very intensive respiratory support, medication needed to assist blood pressure, or need for multiple episodes of cardiopulmonary resuscitation on Days 1-2 of life, among others. 8. Those who have a history of hypersensitivity to the components of this drug. 9. Infant who develops NEC or sepsis prior to randomization must be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of growth [velocity of weight gain (g/kg/day)] (calculated by Patel's exponential method) during the period from birth to 34 weeks and 0 days of gestation will be evaluated to determine whether the rate of growth of subjects in the EHMD group is inferior to that of subjects in the standard nutrition group, with a non-inferiority margin of -1.45 g/kg/day. | — |
Contacts
Public ContactYoshio Kato
DOT WORLD Co., Ltd.
Outcome results
None listed