Trial · NCT07908238
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of women achieving > 500mls expressed breast milk by 14 days' post-partum | from enrolment to two weeks post delivery | |
| Primary | Percentage of women achieving > 500mls by 14 days' post-partum in mothers of preterm infants < 33 weeks gestation and/or 1500 gram | Milk amount from time of enrolment to two weeks post delivery | Mothers of preterm infants \<33 weeks and /or 1500 gram will randomly assigned to early breast pumping group or late breast pumping group as outlined above , the primary outcome is the achieving of more than 500 ml of breast milk by day 14 post delivery. |
| Secondary | Parenteral nutrition days | From the time of enrolment until 6 weeks post menstrual age | Total days of parenteral nutrition until reaching to full feed |
| Secondary | Time to full feeds | From date of randomization until reaching fullfeed | How many days required to reach full feed |
| Secondary | Donor milk use | From the time of enrolment until 6 weeks post menstrual age | The number of participants who required donor milk from birth until discharge |
| Secondary | Central line associated blood stream infections | From the time of enrolment until 6 weeks post menstrual age | The number of participants with any documented central line infection from birth until discharge from hospital .Catheter-related bloodstream infection Clinical signs of sepsis and positive peripheral blood culture in the absence of an obvious source other than CVC with one of the following: Positive semiquantitative (\>15 CFU) or quantitative (\>103 CFU) culture from a part of the catheter with the same organisms isolated peripherally Simultaneous quantitative blood cultures with a ratio of ≥3:1 (CVC vs. peripheral) Time difference of ≤2 hours leading to culture positive between CVC and peripheral cultures. Central line-associated bloodstream infection is primary bloodstream infection in a patient who had a central line within the 48 hours period before development of infection. |
| Secondary | Necrotising enterocolitis | From the time of enrolment until 6 weeks post menstrual age | The number of participants who had any episode of necrotizing enterocolitis as defined by Modified Bell's staging criteria from enrolment to discharge. |
| Secondary | Chronic lung disease | From the time of enrolment until 6 weeks post menstrual age | Total numbers of days of respiratory support for the participant |
| Secondary | Late onset sepsis | From the time of enrolment until 6 weeks post menstrual age | The number of participants who had any documented late onset sepsis, described as documented infection after 72 hours after birth . |
| Secondary | Breastfeeding at hospital discharge | From the time of enrolment until 6 weeks post menstrual age | The number of participants involved in the study discharged home on breast feeding |
| Secondary | Death before hospital discharge | From birth to time and date of death | The number of participants ,time and cause of death during the study period |
| Secondary | Duration of hospitalisation | From date of randomization until the date of discharge home | To duration in days of hospital stay from birth until discharge from hospital |
| Secondary | Parental attitudes and experiences (interviews with parents to access and enhance family centre care model) | From time of birth to discharge from hospital | During study period , we are going to carry out interview with parents on level of education during antenatal period on the use of hospital breast pumping , when and how to access breast pumping device , pain associated with hand expression and breast pumping device . Level of education and support during first weeks after delivery . Added more , we are going to perform eduction sessions to the postnatal and delivery wards staff , NICU staff including Consultants , junior doctors and nursing staff . |
| Secondary | Formula milk | From the time of enrolment until 6 weeks post menstrual age | The number of participants who used of formula milk at any stage after birth until discharge from hospital |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07908238/registered