Feeding Intolerance
Conditions
Brief summary
Feeding intolerance is a common problem in preterm infants.
Interventions
DRUGGlycerin
Glycerin group GG will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery.
PROCEDURERectal stimulation
Rectal stimulation SG by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall.
OTHERControl
Control group CG will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes.
Sponsors
Sulaiman Al Habib Medical Group- Arrayan Hospital
King Saud Medical City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to full feeding (days) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | Days to achieve full enteral feeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of feeding intolerance | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Feeding intolerance defined as feeding withheld, discontinued, or decreased because the infant was not tolerating enteral feedings. |
| Incidence of necrotizing enterocolitis (NEC) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | Necrotizing enterocolitis (NEC) defined as per Bell's staging. |
| Incidence of proven late onset infection | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | Incidence of proven late onset infection defined as clinical signs in addition to positive blood culture beyond 72 hours of age. |
| Incidence of hyperbilirubinemia | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | Incidence of hyperbilirubinemia defined as level of bilirubin requiring treatment with phototherapy according to the bilirubin chart used in the participating unit. |
| Length of hospital stay (days) | At discharge from hospital, an expected average of 8 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Retinopathy of prematurity (ROP) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | Defined by the International Classification of Retinopathy of Prematurity (ICORP) |
| Bronchopulmonary dysplasia (BPD) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | — |
| Patent ductus arteriosus (PDA) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | Diagnosed by echocardiogram |
| Side effects | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | For example: Rectal bleeding, Rectal Perforation, or Hematochezia |
| Growth at discharge from hospital | At discharge from hospital, an expected average of 8 weeks | Growth parameters at discharge from hospital include: Weight (grams), Length (cm), and Head circumference (cm) |
Countries
Saudi Arabia
Contacts
Primary ContactJasim Anabrees
Outcome results
None listed