Feeding Intolerance Clinical Trial
Official title:
Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
Feeding intolerance is a common problem in preterm infants.
Status | Recruiting |
Enrollment | 230 |
Est. completion date | August 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Preterm infants with birth weight equal or less than 1500 g Exclusion Criteria: - Significant congenital malformations - Severity of illness such that death is likely in the first few days after birth |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Saud Medical City | Riyadh | |
Saudi Arabia | Sulaiman Al Habib Medical Group | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Saud Medical City | Sulaiman Al Habib Medical Group- Arrayan Hospital |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Growth at discharge from hospital | Growth parameters at discharge from hospital include: Weight (grams), Length (cm), and Head circumference (cm) | At discharge from hospital, an expected average of 8 weeks | No |
Other | Retinopathy of prematurity (ROP) | Defined by the International Classification of Retinopathy of Prematurity (ICORP) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | No |
Other | Bronchopulmonary dysplasia (BPD) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | No | |
Other | Patent ductus arteriosus (PDA) | Diagnosed by echocardiogram | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | No |
Other | Side effects | For example: Rectal bleeding, Rectal Perforation, or Hematochezia | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | Yes |
Primary | Time to full feeding (days) | Days to achieve full enteral feeding | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | No |
Secondary | Incidence of feeding intolerance | Feeding intolerance defined as feeding withheld, discontinued, or decreased because the infant was not tolerating enteral feedings. | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | No |
Secondary | Incidence of necrotizing enterocolitis (NEC) | Necrotizing enterocolitis (NEC) defined as per Bell's staging. | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | No |
Secondary | Incidence of proven late onset infection | Incidence of proven late onset infection defined as clinical signs in addition to positive blood culture beyond 72 hours of age. | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | No |
Secondary | Incidence of hyperbilirubinemia | Incidence of hyperbilirubinemia defined as level of bilirubin requiring treatment with phototherapy according to the bilirubin chart used in the participating unit. | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | No |
Secondary | Length of hospital stay (days) | At discharge from hospital, an expected average of 8 weeks | No |
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