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NCT04351425
Early Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams
NA trial testing Weaning to crib in Pre-Term in 61 participants. Status unknown.
1 May 2020
Quick facts
| Lead sponsor | King Fahad Medical City |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 61 |
| Start date | 16 April 2020 |
| Primary completion | 1 May 2020 |
| Estimated completion | 30 June 2020 |
Drugs / interventions tested
- Weaning to crib
- Weaning from incubator
Conditions studied
- Pre-Term — all drugs for Pre-Term →
- Body Temperature Changes — all drugs for Body Temperature Changes →
- Transition — all drugs for Transition →
- Patient Discharge — all drugs for Patient Discharge →
Sponsor
King Fahad Medical City — full company profile →
Who can join
Adults 23 Weeks to 34 Weeks, any sex, with Pre-Term or Body Temperature Changes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: To maintain the body temperature of preterm newborns is one of the essential criteria for discharge from hospital. Aim: we aimed to assess the feasibility and the safety of an early weaning protocol from incubator to unheated cot at 1400 g preterm newborns. Methods: This was a randomized control trial with preterm neonates with birth weights \< 1400 g conducted at King Fahad Medical City, Riyadh, Saudi Arabia. We compared newborns weaned to cot at a weight of 1400 g to newborns weaned at a weight of 1600 g. The outcome was to assess the feasibility of the protocol in terms of temperature control and average weight gain. Results: A total of 23 preterm neonates were recruited in this study. The baseline characteristics were similar except for the gestational age was higher in the newborns enrolled to 1400 g group. Early weaning was achieved in 100% of newborns without significant adverse effects on temperature stability or weight gain. Incidence of low and high temperatures per newborn and the average weight gain before and after transfer and after transfer were not different between the two groups. Conclusion: Our results showed the feasibility and safety of 1400 g weaning protocol for preterm newborns, without any adverse effects or increasing the neonatal length of hospital stay. Further investigations in larger patient groups are recommended.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04351425 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King Fahad Medical City
- Last refreshed: 17 April 2020
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