A phase 3 clinical study investigating the effects of rhBSSL (an enzyme to help digestion of fat) added to pasteurized breast milk or formula in babies born prematurely.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 432

Inclusion Criteria

1. Preterm infant born before Week 32 of gestation.
2. Preterm infant who is <33 weeks postmenstrual age at the time of randomization.
3. Preterm infant who is AGA or SGA at birth.
4. Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 mL/kg/day at randomization.
5. Preterm infant whose mother is not willing or is unable to breastfeed, or for whom breast feeding is contraindicated for medical reasons, and who is therefore not expected to receive any fresh breast milk for 4 weeks following treatment initiation.
6. Preterm infant whose enteral feeding consists of only infant formula or only PBM at the time of inclusion, and who is expected to remain on only infant formula for 4 weeks, or only PBM for at least 2 weeks following treatment initiation.
7. Informed consent is obtained from the patient’s legally acceptable representatives
Are the trial subjects under 18? yes
Number of subjects for this age range: 432
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Expected stay at the hospital is less than 4 weeks from the first dose of study drug.
2. Currently receiving mechanical ventilation via endotracheal tube (continuous positive airway pressure [CPAP] or high-flow nasal cannula are not criteria for exclusion).
3. Require =30% oxygen (if on CPAP or in head box) or >0.5 L/min oxygen.
4. Evidence of severe brain disease or damage, including grade III or IV peri- or intraventricular hemorrhage, meningitis or hydrocephalus, grade III or IV intracranial hemorrhage, or periventricular leukomalacia.
5. Presence of major dysmorphology or congenital abnormalities that are likely to affect growth and/or development.
6. Current clinical evidence of hemodynamically significant persistent ductus arteriosus.
7. Clinical evidence of sepsis (including low or high white blood cell count and/or low platelet count and bacteriologically proven evidence of systemic infection). This should be based on the investigator’s opinion and available local laboratory reference ranges. Patients should not have received antibiotics in preceding 48 hours except where these are being administered for prophylaxis as per routine unit protocols (eg, antifungal prophylaxis with fluconazole).
8. Evidence of congenital infection (eg, cytomegalovirus).
9. Previous or current diagnosis of necrotizing enterocolitis (Bell’s stage 2 or greater).
10. Prior or current treatment with corticosteroids, except hydrocortisone.
11. Presence of any condition that in the opinion of the investigator makes the patient unsuitable for inclusion.
12. Enrolled in another concurrent clinical intervention study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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