Tolerance of milk feeds in preterm, very low birth-weight babies: the use of glycerine suppositories
| ISRCTN | ISRCTN47065764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47065764 |
| Clinical Trials Information System (CTIS) | 2005-000302-31 |
| Protocol serial number | 04/S0101/37 (EudraCT number 2005-000302-31) |
| Sponsor | NHS Lanarkshire Primary Care Operating Division (UK) |
| Funder | NHS Lanarkshire Primary Care Operating Division 04/S0101/37 |
- Submission date
- 05/01/2006
- Registration date
- 17/02/2006
- Last edited
- 16/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Samuel Ibhanesebhor
Scientific
Scientific
Wishaw General Hospital
Netherton street
Wishaw
ML2 0DP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, open, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does the use of regular glycerine suppositories shorten the time to first achievement of full enteral feeds in preterm, very low birth-weight infants? |
| Ethics approval(s) | Awaiting final approval |
| Health condition(s) or problem(s) studied | Feeding problems related to prematurity |
| Intervention | Glycerine suppositories, control group will receive usual neonetal care following randomisation |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glycerine suppositories |
| Primary outcome measure(s) |
Time to achieve first full enteral feeds |
| Key secondary outcome measure(s) |
1. Number of episodes of abdominal distention |
| Completion date | 06/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 28 |
| Key inclusion criteria | All preterm babies born at Wishaw General Hospital at less than 32 weeks gestation |
| Key exclusion criteria | Babies with any of the following will be excluded: 1. Major dysmorphic features 2. Any structural gastrointestinal anomaly present 3. Necrotising enterocolitis (NEC) 4. Perinatal hypoxic ischemia 5. Encephalopathy |
| Date of first enrolment | 06/02/2006 |
| Date of final enrolment | 06/02/2007 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Wishaw General Hospital
Wishaw
ML2 0DP
United Kingdom
ML2 0DP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2011 | Yes | No |
