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Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02149407
Recruitment Status : Unknown
Verified April 2015 by King Saud Medical City.
Recruitment status was:  Recruiting
First Posted : May 29, 2014
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Sulaiman Al Habib Medical Group- Arrayan Hospital
Information provided by (Responsible Party):
King Saud Medical City

Brief Summary:
Feeding intolerance is a common problem in preterm infants.

Condition or disease Intervention/treatment Phase
Feeding Intolerance Drug: Glycerin Procedure: Rectal stimulation Other: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glycerin

Arm Intervention/treatment
Active Comparator: Glycerin group (GG)
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.
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.
Other Name: Glycerine

Active Comparator: Rectal stimulation group (SG)
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.
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.

Sham Comparator: Control group (CG)
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.
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.




Primary Outcome Measures :
  1. Time to full feeding (days) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    Days to achieve full enteral feeding


Secondary Outcome Measures :
  1. Incidence of feeding intolerance [ Time Frame: 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.

  2. Incidence of necrotizing enterocolitis (NEC) [ Time Frame: 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.

  3. Incidence of proven late onset infection [ Time Frame: 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.

  4. Incidence of hyperbilirubinemia [ Time Frame: 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.

  5. Length of hospital stay (days) [ Time Frame: At discharge from hospital, an expected average of 8 weeks ]

Other Outcome Measures:
  1. Growth at discharge from hospital [ Time Frame: 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)

  2. Retinopathy of prematurity (ROP) [ Time Frame: 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)

  3. Bronchopulmonary dysplasia (BPD) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
  4. Patent ductus arteriosus (PDA) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
    Diagnosed by echocardiogram

  5. Side effects [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
    For example: Rectal bleeding, Rectal Perforation, or Hematochezia



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149407


Contacts
Contact: Jasim Anabrees jasim1800@yahoo.com

Locations
Saudi Arabia
King Saud Medical City Recruiting
Riyadh, Saudi Arabia
Contact: Latifa Almahmoud       latifa369@yahoo.com   
Principal Investigator: latifa Almahmoud         
Sub-Investigator: Haider Somaily         
Sub-Investigator: Nabeel Al-Odaisan         
Sub-Investigator: Sadia Al-Shehri         
Sulaiman Al Habib Medical Group Not yet recruiting
Riyadh, Saudi Arabia
Contact: Jasim Anabrees, FRCPCH       jasim1800@yahoo.com   
Principal Investigator: Jasim Anabrees, FRCPCH         
Sponsors and Collaborators
King Saud Medical City
Sulaiman Al Habib Medical Group- Arrayan Hospital
Investigators
Study Chair: Latifa Almahmoud, MD KSMC

Responsible Party: King Saud Medical City
ClinicalTrials.gov Identifier: NCT02149407     History of Changes
Other Study ID Numbers: 0752
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs