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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02149407
Other study ID # 0752
Secondary ID
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


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
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