Feeding intolerance is a common problem in preterm infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
230
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.
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.
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.
King Saud Medical City
Riyadh, Saudi Arabia
RECRUITINGSulaiman Al Habib Medical Group
Riyadh, Saudi Arabia
NOT_YET_RECRUITINGTime to full feeding (days)
Days to achieve full enteral feeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Incidence of feeding intolerance
Feeding intolerance defined as feeding withheld, discontinued, or decreased because the infant was not tolerating enteral feedings.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of necrotizing enterocolitis (NEC)
Necrotizing enterocolitis (NEC) defined as per Bell's staging.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
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.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
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.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Length of hospital stay (days)
Time frame: At discharge from hospital, an expected average of 8 weeks
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