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New treatment option for Meconium Obstruction of Prematurity
Official title Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
ClinicalTrials.gov ID: NCT06048614
What this study is testing
What is Glycerin Suppository?
Glycerin Suppository is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for meconium obstruction of prematurity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to study the effect of twice-daily saline enema (SE) in the treatment obstruction of prematurity (MOP) in infants with the birth weight ≤1.25kg. The main questions, the trial aims to answer are 1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 36. Healthy volunteers may be eligible.
You may be able to join if
- Criteria A: For infant presenting with early onset of MOP
- Birth weight 500 - 1250 gram
- ≥ 23 weeks gestation
- No BO for 48 hours
- BO present but with a small amount or stain of meconium
You likely can't join if
- Infants that:
- Neuromuscular disorder
- Moderate or severe asphyxia
- Inability to start enteral feeding, which continued for 3 consecutive days before 2 weeks of post-natal age for reasons unrelated to meconium...
- Without parental consent
- Aggravated medical instability
See the full eligibility criteria
- Criteria A: For infant presenting with early onset of MOP
- Birth weight 500 - 1250 gram
- ≥ 23 weeks gestation
- No BO for 48 hours
- BO present but with a small amount or stain of meconium
- Feeds intolerance or abdominal X-ray showing dilated loops of bowel
- Criteria B: For infant presenting with Late onset of MOP
- Birth weight 500 - 1250 gram
- ≥ 23 weeks gestation
- Infants who passed meconium initially and develop evidence of meconium obstruction at a later age (feed intolerance or vomiting and abnormal abdominal X-ray with or without abdominal distension)
- Infants that:
- Neuromuscular disorder
- Moderate or severe asphyxia
- Inability to start enteral feeding, which continued for 3 consecutive days before 2 weeks of post-natal age for reasons unrelated to meconium inspissation or its complication
- Without parental consent
- Aggravated medical instability
- Single mothers \< 21 years
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 36 weeks. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.