Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

Feeding Intolerance Clinical Trial

Official title:

Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02149407
• Other study ID #: 0752
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2014
• Last updated: April 2, 2015
• Start date: May 2014
• Est. completion date: August 2016

Study information

• Verified date: April 2015
• Source: King Saud Medical City
• Contact: Jasim Anabrees
• Email: jasim1800[@]yahoo.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Feeding intolerance is a common problem in preterm infants.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Feeding Intolerance

Intervention

Drug:
• Glycerin
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.

Procedure:
• Rectal 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.

Other:
• Control
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.

Locations

Country	Name	City	State
Saudi Arabia	King Saud Medical City	Riyadh
Saudi Arabia	Sulaiman Al Habib Medical Group	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud Medical City	Sulaiman Al Habib Medical Group- Arrayan Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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