Meconium Obstruction of PrematurityNCT06048614
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
A study testing Saline Enema (SE) and Glycerin Suppository in people with Meconium Obstruction of Prematurity, run by KK Women's and Children's Hospital at 2 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Meconium Obstruction of Prematurity
- What is being tested?
- Saline Enema (SE) and Glycerin Suppository
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesSingapore
- Study dates
- 2 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Sridhar Sr Arunachalam, FAMS, 94570746 ext. 4597, sridhar.arunachalam@singhealth.com.sg
Chritina titin, 81208069 ext. 2802, christina.titin@singhealth.com.sg
- Recruiting
KK Women's and Children Hospital
Singapore, 229899
Seow Ching Li, li.seow.ching@kkh.com.sg
Wen Yi Wan, wan.wen.yi@kkh.com.sg
About this study
Official title: The Administration of Saline Enema Versus Glycerin Suppository as a Treatment Intervention for Meconium Obstruction of Prematurity (MOP) and to Study the Impact on the Resolution of MOP, Time to Reach Full Enteral Feeds, Gut Microbiome, and Gut-brain Axis, a Randomised Control Trial.
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
- To validate the finding of our pilot study which had shown that twice-daily SE reduces the time to reach full enteral feeds in premature infant as compared to premature infant treated with Glycerine Suppository (GS), in a larger cohort. Infant with MOP fails to pass meconium in the first 48 hours of life and develop symptoms and signs like abdominal distension and feed intolerance.
- The other aims of this study are to test whether the intervention is
- Effective treatment for MOP
- Reduce the duration of ICU stay
- Reduce the rate of necrotizing enterocolitis, sepsis, Total Parenteral Nutrition (TPN) days and number of intravenous catheter days
- The study also wants to explore the impact of this intervention on the gut microbiome, gut-brain interaction and immune response of the new-born.
Read the detailed description
Very low birth weight infants (VLBW ≤ 1.5 kg) constitute more than 60% of bed occupancy in level III neonatal units. They face the risk of 10-50% long-term disability, and their initial healthcare cost ranges from S$50,000 to 1 million, an important healthcare issue.
The incidence of meconium obstruction of prematurity (MOP) is 20-30% in extremely low birth weight (ELBW ≤ 1 kg) infants. The intervention based on the current standard of care increase the risk of laparotomy necrotizing enterocolitis, intestinal perforation, and neurodevelopmental risks posed by general anaesthesia. Our published pilot RCT demonstrated that saline enema (SE) is an effective, feasible, and safe intervention to reduce the time to reach full enteral feeds and is a potentially effective treatment for MOP in ELBW (< 1 kg) infants.
Our primary hypothesis is that Infants with Twice-daily high-volume SE (20-40 ml/kg/day) intervention will result in reduced time to reach full enteral feeds compared to infants treated with conventional management with Glycerin suppository (GS) in (≤1.25kg) infants with MOP. Our exploratory hypothesis is that SE will have a protective effect on the gut microbiome, inflammatory and immune response in preterm infants.
Ninety-five infants born over three years in KK Hospital (KKH) and Singapore General Hospital (SGH) will be enrolled and randomized at 48 hours or later to receive SE or GS. The standardized protocol will be used for the accreditation and administration of SE. Primary, secondary, and exploratory outcomes data, including treatment failure data, will be recorded. Infants will be followed up to 36 weeks of gestation or discharge, whichever is earlier. Maternal and infant characteristics, inflammatory and immune response, and safety outcome data will be collected.
If the findings of our pilot trial are confirmed, the protocol can become the standard of care in preterm infants with MOP. Additionally, significant healthcare cost savings will be realized alongside an improved understanding of the Microbiome, immune and inflammatory response pertaining to the gut.
- Conditions
- Meconium Obstruction of Prematurity
- Being tested
- Saline Enema (SE), Glycerin Suppository
- Medical subject headings
- Meconium Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Enema (SE)Procedure or surgery
infant who allocated with intervention group will proceed with SE with normal saline (20-40ml/kg twice daily) at 48 hours of age. Then continue until 2 days of yellow stools/ 110ml/kg/day of oral feeds; whichever is earlier.
SE are recommended if baby do not do bowel opening (BO) for 2 days before reaching full feeds
Failure to resolve the MOP with SE will be designated as treatment failure and managed with contrast enema or Laparotomy by paediatric surgeons, following a formal referral.GS is not allowed in intervention arm
Glycerin SuppositoryDrug
Infants randomized to GS received the standard management protocol for meconium retention in the unit. GS (2,000 mg, a quarter unit, four doses 12 h apart) were administered to infants earliest at 48 hour to 72 hours of birth, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who were diagnosed with meconium obstruction later in the first 2 weeks of life were also treated with glycerin suppositories for 48 hrs, with subsequent once-daily GS being administered at the discretion of the managing team.
Infants who failed to respond to glycerin suppositories were referred to the surgical team by the managing team The subsequent management of meconium retention was at the surgeon's discretion and included continued GS by the surgical team, contrast enema or surgical interventions performed in escalating order as mentioned.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Saline Enema Arm) | Experimental | After randomisation, infant who allocated with intervention group will proceed with SE with normal saline (20-40ml/kg twice daily) earliest at 48 to 72 hours of age. Then continue until 2 days of yellow stools/ 110ml/kg/day of oral feeds; whichever is earlier.
SE are recommended if baby do not do bowel opening (BO) for 2 days before reaching full feeds Receives: Procedure: Saline Enema (SE) |
| Control Arm (Glycerin Suppository Arm) | Active comparator | Infants randomized to GS received the standard management protocol for meconium retention in the unit. GS (2,000 mg, a quarter unit, four doses 12 h apart) were administered to infants earliest at 48 hour to 72 hours of birth, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who were diagnosed with meconium obstruction later in the first 2 weeks of life were also treated with glycerin suppositories for 48 hrs, with subsequent once-daily GS being administered at the discretion of the managing team.
Infants who failed to respond to glycerin suppositories were referred to the surgical team by the managing team The subsequent management of meconium retention was at the surgeon's discretion and included continued GS by the surgical team, contrast enema or surgical interventions performed in escalating order as mentioned. Receives: Drug: Glycerin Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach full enteral feeds in days
Time to reach full enteral feeds is measured from birth to the time infant reaches full oral milk feeds.
Full oral milk feed is defined as milk volume of 110ml/kg/day. The total parenteral nutrition is discontinued when infant reaches milk feed volume of 110ml/kg/day.
Rationale:
SE loosens the thick and sticky meconium by saline absorption and triggers effective and strong peristaltic contractions, thereby leading to the evacuation of meconium from the gut. The evacuation of meconium leads to the resolution of the gut obstruction, thereby enhancing feed tolerance in premature infants with meconium obstruction of prematurity.
Measured: Before 36 weeks of corrected age of discharge of the infant
Secondary outcomes (4)
Rate of treatment failure
Treatment failure is defined as the need to use additional treatment measures, apart from the study intervention to resolve MOP in the study cohort.
Measured: Before 36 weeks of corrected age of discharge of the infant
Rate of (a) Culture positive sepsis (b) Necrotising enterocolitis.
Rationale:
If twice daily SE leads to the shortening of time to reach full enteral feeds, resolution of MOP, and promote friendly bacteria microbiome, then it has the potential to reduce NICU stay, risk of necrotising enterocolitis, risk of sepsis, duration of total parenteral nutrition, duration of PICC and overall cost of care.
Measured: Before 36 weeks of corrected age of discharge of the infant
Duration in days of (a) ICU stay (b) Total parenteral nutrition (c) PICC days.
Rationale:
If twice daily SE leads to the shortening of time to reach full enteral feeds, resolution of MOP, and promote friendly bacteria microbiome, then it has the potential to reduce NICU stay, risk of necrotising enterocolitis, risk of sepsis, duration of total parenteral nutrition, duration of PICC and overall cost of care.
Measured: Before 36 weeks of corrected age of discharge of the infant
Overall cost of care calculated in SGD at the time of discharge
Rationale:
If twice daily SE leads to the shortening of time to reach full enteral feeds, resolution of MOP, and promote friendly bacteria microbiome, then it has the potential to reduce NICU stay, risk of necrotising enterocolitis, risk of sepsis, duration of total parenteral nutrition, duration of PICC and overall cost of care.
Measured: Before 36 weeks of corrected age of discharge of the infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Jan 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Meconium Obstruction of PrematurityStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group will receive SE with normal saline (20-40 ml/kg/per SE) 2 times a day at 48 to 72 hrs of age at the earliest. The infant with medical instability procedure will be deferred until the infant is medically fit and intervention is continued until the infant reaches full feeds, defined as 110 ml/kg/day or yellow stools whichever is earlier. SE will be recommenced if the infant does not open bowel for 2 days before reaching full feeds. In ≤ 750 grams infant, paediatric surgeons would perform the first catheterisation with 6F catheter, insertion length will be limited to 8 cm, and saline is infused with the aid of gravity. Syringe flushing is allowed if gravity force fail to drive saline to the intestine.Two ultrasound abdominal examination will be performed and first scan will coincide with first SE in 500-750 grams infants.Failure to resolve the MOP with SE will be designated as treatment failure and managed with contrast enema or Laparotomy by paediatric surgeons.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singapore General Hospital, Genome Institute of Singapore, Translational Immunology Institute, Duke-NUS Graduate Medical School
- Responsible party
- Principal investigator, Thowfique Kadavukarayil Ibrahim, KK Women's and Children's Hospital
- Investigators
- Thowfique Ibrahim, FRCPCH, FAMS, Principal investigator, Singhealth Duke-NUS Medical School, NUS and LKC Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048614
- Sponsor's protocol ID
- 2023/2270
- Status last verified
- May 2025
- First submitted
- 3 Aug 2023
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unger A, Goetzman BW, Chan C, Lyons AB 3rd, Miller MF. Nutritional practices and outcome of extremely premature infants. Am J Dis Child. 1986 Oct;140(10):1027-33. doi: 10.1001/archpedi.1986.02140240073029.
PubMed 3092638Chathas MK, Paton JB, Fisher DE. Percutaneous central venous catheterization. Three years' experience in a neonatal intensive care unit. Am J Dis Child. 1990 Nov;144(11):1246-50. doi: 10.1001/archpedi.1990.02150350078030.
PubMed 2239866Stoll BJ, Gordon T, Korones SB, Shankaran S, Tyson JE, Bauer CR, Fanaroff AA, Lemons JA, Donovan EF, Oh W, Stevenson DK, Ehrenkranz RA, Papile LA, Verter J, Wright LL. Late-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1996 Jul;129(1):63-71. doi: 10.1016/s0022-3476(96)70191-9.
PubMed 8757564Shim SY, Kim HS, Kim DH, Kim EK, Son DW, Kim BI, Choi JH. Induction of early meconium evacuation promotes feeding tolerance in very low birth weight infants. Neonatology. 2007;92(1):67-72. doi: 10.1159/000100804. Epub 2007 Mar 14.
PubMed 17356305Krasna IH, Rosenfeld D, Salerno P. Is it necrotizing enterocolitis, microcolon of prematurity, or delayed meconium plug? A dilemma in the tiny premature infant. J Pediatr Surg. 1996 Jun;31(6):855-8. doi: 10.1016/s0022-3468(96)90153-0.
PubMed 8783123Emil S, Nguyen T, Sills J, Padilla G. Meconium obstruction in extremely low-birth-weight neonates: guidelines for diagnosis and management. J Pediatr Surg. 2004 May;39(5):731-7. doi: 10.1016/j.jpedsurg.2004.01.027.
PubMed 15137008Haiden N, Norooz F, Klebermass-Schrehof K, Horak AS, Jilma B, Berger A, Repa A. The effect of an osmotic contrast agent on complete meconium evacuation in preterm infants. Pediatrics. 2012 Dec;130(6):e1600-6. doi: 10.1542/peds.2011-3634. Epub 2012 Nov 26.
PubMed 23184118Broussard DL. Gastrointestinal motility in the neonate. Clin Perinatol. 1995 Mar;22(1):37-59.
PubMed 7781255Dumont RC, Rudolph CD. Development of gastrointestinal motility in the infant and child. Gastroenterol Clin North Am. 1994 Dec;23(4):655-71.
PubMed 7698826Campbell BG, Couceyro P, Keana JF, Weber E. N-methyl-D-aspartate receptor-mediated contractions of the guinea pig ileum longitudinal muscle/myenteric plexus preparation: modulation by phencyclidine and glycine receptors. J Pharmacol Exp Ther. 1991 May;257(2):754-66.
PubMed 1674535Siddiqui MM, Drewett M, Burge DM. Meconium obstruction of prematurity. Arch Dis Child Fetal Neonatal Ed. 2012 Mar;97(2):F147-50. doi: 10.1136/adc.2010.190157. Epub 2010 Nov 29.
PubMed 21115553Juang D, Snyder CL. Neonatal bowel obstruction. Surg Clin North Am. 2012 Jun;92(3):685-711, ix-x. doi: 10.1016/j.suc.2012.03.008. Epub 2012 Apr 17.
PubMed 22595716Kim YJ, Kim EK, Kim ES, Kim HS, Choi JH, Cheon JE, Kim WS, Kim IO, Park KW. Recognition, diagnosis and treatment of meconium obstruction in extremely low birth weight infants. Neonatology. 2012;101(3):172-8. doi: 10.1159/000330850. Epub 2011 Oct 22.
PubMed 22024741Garza-Cox S, Keeney SE, Angel CA, Thompson LL, Swischuk LE. Meconium obstruction in the very low birth weight premature infant. Pediatrics. 2004 Jul;114(1):285-90. doi: 10.1542/peds.114.1.285.
PubMed 15231948Cho HH, Cheon JE, Choi YH, Lee SM, Kim WS, Kim IO, Shin SM, Kim EK, Kim HS, Choi JH, You SK. Ultrasound-guided contrast enema for meconium obstruction in very low birth weight infants: Factors that affect treatment success. Eur J Radiol. 2015 Oct;84(10):2024-31. doi: 10.1016/j.ejrad.2015.06.006. Epub 2015 Jun 7.
PubMed 26159485
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Administration of Saline Enema Versus Glycerin Suppository as a Treatment Intervention for Meconium Obstruction of Prematurity (MOP) and to Study the Impact on the Resolution of MOP, Time to Reach Full Enteral Feeds, Gut Microbiome, and Gut-brain Axis, a Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT06048614
- Acronym / sponsor ID
- 2023/2270
- Conditions
- Meconium Obstruction of Prematurity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore General Hospital, Genome Institute of Singapore, Translational Immunology Institute, Duke-NUS Graduate Medical School
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To validate the finding of our pilot study which had shown that twice-daily SE reduces the time to reach full enteral feeds in premature infant as compared to premature infant treated with Glycerine Suppository (GS), in a larger cohort. Infant with MOP fails to pass meconium in the first 48 hours of life and develop symptoms and signs like abdominal distension and feed intolerance.
- The other aims of this study are to test whether the intervention is
- Effective treatment for MOP
- Reduce the duration of ICU stay
- Reduce the rate of necrotizing enterocolitis, sepsis, Total Parenteral Nutrition (TPN) days and number of intravenous catheter days
- The study also wants to explore the impact of this intervention on the gut microbiome, gut-brain interaction and immune response of the new-born.
Detailed description
Very low birth weight infants (VLBW ≤ 1.5 kg) constitute more than 60% of bed occupancy in level III neonatal units. They face the risk of 10-50% long-term disability, and their initial healthcare cost ranges from S$50,000 to 1 million, an important healthcare issue.
The incidence of meconium obstruction of prematurity (MOP) is 20-30% in extremely low birth weight (ELBW ≤ 1 kg) infants. The intervention based on the current standard of care increase the risk of laparotomy necrotizing enterocolitis, intestinal perforation, and neurodevelopmental risks posed by general anaesthesia. Our published pilot RCT demonstrated that saline enema (SE) is an effective, feasible, and safe intervention to reduce the time to reach full enteral feeds and is a potentially effective treatment for MOP in ELBW (< 1 kg) infants.
Our primary hypothesis is that Infants with Twice-daily high-volume SE (20-40 ml/kg/day) intervention will result in reduced time to reach full enteral feeds compared to infants treated with conventional management with Glycerin suppository (GS) in (≤1.25kg) infants with MOP. Our exploratory hypothesis is that SE will have a protective effect on the gut microbiome, inflammatory and immune response in preterm infants.
Ninety-five infants born over three years in KK Hospital (KKH) and Singapore General Hospital (SGH) will be enrolled and randomized at 48 hours or later to receive SE or GS. The standardized protocol will be used for the accreditation and administration of SE. Primary, secondary, and exploratory outcomes data, including treatment failure data, will be recorded. Infants will be followed up to 36 weeks of gestation or discharge, whichever is earlier. Maternal and infant characteristics, inflammatory and immune response, and safety outcome data will be collected.
If the findings of our pilot trial are confirmed, the protocol can become the standard of care in preterm infants with MOP. Additionally, significant healthcare cost savings will be realized alongside an improved understanding of the Microbiome, immune and inflammatory response pertaining to the gut.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment group will receive SE with normal saline (20-40 ml/kg/per SE) 2 times a day at 48 to 72 hrs of age at the earliest. The infant with medical instability procedure will be deferred until the infant is medically fit and intervention is continued until the infant reaches full feeds, defined as 110 ml/kg/day or yellow stools whichever is earlier. SE will be recommenced if the infant does not open bowel for 2 days before reaching full feeds. In ≤ 750 grams infant, paediatric surgeons would perform the first catheterisation with 6F catheter, insertion length will be limited to 8 cm, and saline is infused with the aid of gravity. Syringe flushing is allowed if gravity force fail to drive saline to the intestine.Two ultrasound abdominal examination will be performed and first scan will coincide with first SE in 500-750 grams infants.Failure to resolve the MOP with SE will be designated as treatment failure and managed with contrast enema or Laparotomy by paediatric surgeons.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Saline Enema Arm) | Experimental | Procedure: Saline Enema (SE)After randomisation, infant who allocated with intervention group will proceed with SE with normal saline (20-40ml/kg twice daily) earliest at 48 to 72 hours of age. Then continue until 2 days of yellow stools/ 110ml/kg/day of oral feeds; whichever is earlier. SE are recommended if baby do not do bowel opening (BO) for 2 days before reaching full feeds |
| Control Arm (Glycerin Suppository Arm) | Active comparator | Drug: Glycerin SuppositoryInfants randomized to GS received the standard management protocol for meconium retention in the unit. GS (2,000 mg, a quarter unit, four doses 12 h apart) were administered to infants earliest at 48 hour to 72 hours of birth, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who were diagnosed with meconium obstruction later in the first 2 weeks of life were also treated with glycerin suppositories for 48 hrs, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who failed to respond to glycerin suppositories were referred to the surgical team by the managing team The subsequent management of meconium retention was at the surgeon's discretion and included continued GS by the surgical team, contrast enema or surgical interventions performed in escalating order as mentioned. |
Who may qualify
- Ages
- 1 day to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Criteria A: For infant presenting with early onset of MOP
- Criteria B: For infant presenting with Late onset of MOP
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Enema (SE)infant who allocated with intervention group will proceed with SE with normal saline (20-40ml/kg twice daily) at 48 hours of age. Then continue until 2 days of yellow stools/ 110ml/kg/day of oral feeds; whichever is earlier. SE are recommended if baby do not do bowel opening (BO) for 2 days before reaching full feeds Failure to resolve the MOP with SE will be designated as treatment failure and managed with contrast enema or Laparotomy by paediatric surgeons, following a formal referral.GS is not allowed in intervention arm | Procedure or surgery | Intervention Arm (Saline Enema Arm) |
| Glycerin SuppositoryInfants randomized to GS received the standard management protocol for meconium retention in the unit. GS (2,000 mg, a quarter unit, four doses 12 h apart) were administered to infants earliest at 48 hour to 72 hours of birth, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who were diagnosed with meconium obstruction later in the first 2 weeks of life were also treated with glycerin suppositories for 48 hrs, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who failed to respond to glycerin suppositories were referred to the surgical team by the managing team The subsequent management of meconium retention was at the surgeon's discretion and included continued GS by the surgical team, contrast enema or surgical interventions performed in escalating order as mentioned. | Drug | Control Arm (Glycerin Suppository Arm) |
Primary outcome
Time to reach full enteral feeds in days
Time frame: Before 36 weeks of corrected age of discharge of the infant
Time to reach full enteral feeds is measured from birth to the time infant reaches full oral milk feeds. Full oral milk feed is defined as milk volume of 110ml/kg/day. The total parenteral nutrition is discontinued when infant reaches milk feed volume of 110ml/kg/day. Rationale: SE loosens the thick and sticky meconium by saline absorption and triggers effective and strong peristaltic contractions, thereby leading to the evacuation of meconium from the gut. The evacuation of meconium leads to the resolution of the gut obstruction, thereby enhancing feed tolerance in premature infants with meconium obstruction of prematurity.
4 secondary outcomes
Rate of treatment failure
Time frame: Before 36 weeks of corrected age of discharge of the infant
Rate of (a) Culture positive sepsis (b) Necrotising enterocolitis.
Time frame: Before 36 weeks of corrected age of discharge of the infant
Duration in days of (a) ICU stay (b) Total parenteral nutrition (c) PICC days.
Time frame: Before 36 weeks of corrected age of discharge of the infant
Overall cost of care calculated in SGD at the time of discharge
Time frame: Before 36 weeks of corrected age of discharge of the infant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 3092638Unger A, Goetzman BW, Chan C, Lyons AB 3rd, Miller MF. Nutritional practices and outcome of extremely premature infants. Am J Dis Child. 1986 Oct;140(10):1027-33. doi: 10.1001/archpedi.1986.02140240073029.
- Background: PubMed 2239866Chathas MK, Paton JB, Fisher DE. Percutaneous central venous catheterization. Three years' experience in a neonatal intensive care unit. Am J Dis Child. 1990 Nov;144(11):1246-50. doi: 10.1001/archpedi.1990.02150350078030.
- Background: PubMed 8757564Stoll BJ, Gordon T, Korones SB, Shankaran S, Tyson JE, Bauer CR, Fanaroff AA, Lemons JA, Donovan EF, Oh W, Stevenson DK, Ehrenkranz RA, Papile LA, Verter J, Wright LL. Late-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1996 Jul;129(1):63-71. doi: 10.1016/s0022-3476(96)70191-9.
- Background: PubMed 17356305Shim SY, Kim HS, Kim DH, Kim EK, Son DW, Kim BI, Choi JH. Induction of early meconium evacuation promotes feeding tolerance in very low birth weight infants. Neonatology. 2007;92(1):67-72. doi: 10.1159/000100804. Epub 2007 Mar 14.
- Background: PubMed 8783123Krasna IH, Rosenfeld D, Salerno P. Is it necrotizing enterocolitis, microcolon of prematurity, or delayed meconium plug? A dilemma in the tiny premature infant. J Pediatr Surg. 1996 Jun;31(6):855-8. doi: 10.1016/s0022-3468(96)90153-0.
- Background: PubMed 15137008Emil S, Nguyen T, Sills J, Padilla G. Meconium obstruction in extremely low-birth-weight neonates: guidelines for diagnosis and management. J Pediatr Surg. 2004 May;39(5):731-7. doi: 10.1016/j.jpedsurg.2004.01.027.
- Background: PubMed 23184118Haiden N, Norooz F, Klebermass-Schrehof K, Horak AS, Jilma B, Berger A, Repa A. The effect of an osmotic contrast agent on complete meconium evacuation in preterm infants. Pediatrics. 2012 Dec;130(6):e1600-6. doi: 10.1542/peds.2011-3634. Epub 2012 Nov 26.
- Background: PubMed 7781255Broussard DL. Gastrointestinal motility in the neonate. Clin Perinatol. 1995 Mar;22(1):37-59.
- Background: PubMed 7698826Dumont RC, Rudolph CD. Development of gastrointestinal motility in the infant and child. Gastroenterol Clin North Am. 1994 Dec;23(4):655-71.
- Background: PubMed 1674535Campbell BG, Couceyro P, Keana JF, Weber E. N-methyl-D-aspartate receptor-mediated contractions of the guinea pig ileum longitudinal muscle/myenteric plexus preparation: modulation by phencyclidine and glycine receptors. J Pharmacol Exp Ther. 1991 May;257(2):754-66.
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- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thowfique Ibrahim, FRCPCH, FAMS principal investigator
Singhealth Duke-NUS Medical School, NUS and LKC Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Enema (SE) and Glycerin Suppository in people with Meconium Obstruction of Prematurity, run by KK Women's and Children's Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seow Ching Li, Biomedical (63948005 ext. 8005, li.seow.ching@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach full enteral feeds in days (time frame: Before 36 weeks of corrected age of discharge of the infant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048614, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.