Pre-TermNCT04351425
Early Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams
A study testing Weaning to crib and Weaning from incubator in people with Pre-Term and Body Temperature Changes, run by King Fahad Medical City.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 23 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Pre-Term, Body Temperature Changes, Transition
- What is being tested?
- Weaning to crib and Weaning from incubator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 23 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical weight less than 1.5 kg at birth
- Clinically stable
- No cardio or respiratory support
- Reached 2/3 of his/her enteral feeding
Who cannot join
- IUGR
- Clinical unstable
- On cardio or respiratory support
- Dysmorphic
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility and Safety of Earlier Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams
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.
Read more
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.
Read the detailed description
- Introduction To discharge a preterm newborn after staying in neonatal intensive care unit (NICU) is a multifactorial decision. According to the American Academy of pediatrics guidelines of the physiologic competencies for hospital discharge of the high-risk neonate including preterm ones, are sufficient oral feeding and mature respiratory control, and finally the ability to maintain a normal body temperature in an unheated open bed (1). These mostly are achieved between 36 and 37 weeks' postmenstrual age (2-4). Shortening the period of a hospital stay, it could be beneficial to decrease the emotional stress resulted from the separation between the mother and the newborn and parents; furthermore, it may reduce the hospital-acquired co-morbidities as sepsis and surgical needs (5) and accordingly reduce the economic burden on the society. The timing to wean from the incubator is crucial since the immaturity of preterm newborn's thermoregulatory mechanisms which could affect weight gain as an attempt to maintain body temperature, achieving full feeding volume, and as a result could delay discharge from hospital (6, 7). The target weight for incubator weaning varies widely among NICUs. The common usual practice is between of 1700-1800 g, and it is generally based on the professional experience and judgment (8, 9). In 2010, a Cochrane Review assessed transferring preterm infants from incubator to open bed at a lower body weight (˂1700 g) by comparing to a higher body weight (˃ 1700 g). The review showed that preterm newborns can be transferred to open beds at 1600 g without adverse effects on temperature stability in terms of return to incubator or daily weight gain (10). A multicenter trial achieved the same result (11). Moreover, there are few studies showed that infants can be successfully transferred into cots at weights down to 1500 g (9, 12). A pilot study carried out stepwise four cohort trials of newborn's transfer from incubators to open beds at 1800 g, then at 1700 g, then at 1600 g and then finally at 1500 g (13). It demonstrated that there were no significant differences between the four cohorts in maintain body temperature after incubator weaning. The primary outcome of this study was to evaluate the feasibility and safety of incubator weaning for medically stable preterm neonates to unheated open cot at a body weight of 1400 g in terms of daily weight gain and temperature control. Newborns in the same study period were compared to a control group weaned at body weight of 1600 g.
- Subjects and Methods:
2.1. Study design A prospective randomized clinical trial was conducted at NICU at King Fahad Medical City, Riyadh, Saudi Arabia. Preterm newborns admitted to NICU fulfilling items in inclusion and exclusion criteria during the period from August 2017 to October 2018 were included into the study.
All eligible newborns were randomized into two groups to be weaned at 1,400 or at 1,600 g in a 1:1 ratio, using random block of 4. Newborns were eligible if body weight less than 1400 g, they were at least 5 days of age at the time of transferring to cot, they fed at least 60 ml/kg/day at the time of transferring to cot, and they are medically stable with no significant apnea or bradycardia, no ventilator support, no phototherapy and not having a major congenital abnormality. Newborns were excluded if they didn't fulfill the above criteria or unlikely to reach the target weight within 7 days.
2.2. Procedures Nursery temperatures were adjusted at 24-28 ◦c from birth to cot. The subjects were dressed in a hat, one vest and two wraps. Then, they were randomly assigned to either study group or control group. Infants were weighed naked daily. In the study group, the newborns were transferred to cot at a weight of 1400 to 1499 g and in the control group; they were transferred at a weight of 1600 to 1699 g. In the first day in the open cot, they were not bathed.
2.3. Data Collected
- Baseline characteristics as birth weight, gestational age (GA), gender, age in days in the transfer day, body weight and GA in the transfer day.
- Relevant data from to incubator weaning
- After transfer, hourly axillary temperatures were taken until two consecutive readings between 36.4 and 37.1 °C. Then, temperatures were taken every 3 hours with each feed for at least 72 hours. After that, temperatures were taken four times a day minimum until discharge. If the axillary temperature was ˂36.4°C, thus an additional wrap was added. If the temperature was still low for an hour later, then the infant was returned to the incubator. Meanwhile, if the temperature was more than 37.1°C, a wrap was reduced.
- No of infants who failed to be transferred to cot. Failure of transfer is defined as the inability to maintained body temperatures above 36.4°C in a two consecutive axillary temperatures in a cot despite of adding covering.
- For infants who remained in an open crib, the rate of weight gain calculated every day over the week before and after transfer. In the discharge day, age in days after transfer to discharge date, WT and GA.
2.4. Statistical methodology: Data were statistically described in terms of mean ± SD for continuous data and in frequencies (number of cases). For comparative purposes between groups in all continuous data, independent t-test or Mann Whitney t test was adopted. X2-square and fisher test were used for assessing association in categorical data.. P values less than 0.05 were considered statistically significant. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 21 for Microsoft Windows.
2.5. Ethical considerations: Due to safety concerns, the study was carried out in two steps. Initially, we started infants' weaning with the approved weaning weight at1500 grams. A total of 19 preterm infants were randomized in two groups. Both groups were weaned to cot with a 100% success rate without any complications. Afterwards, the study was approved by the local Ethics Committee to start the second phase of the study at weaning weight of 1400 g. The parents were all directly contacted and agreed in writing informed consent.
- Being tested
- Weaning to crib, Weaning from incubator
- Keywords
- Preterm, Patient discharge, Length of stay, Low birth weight
- Medical subject headings
- Premature Birth, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning to cribDevice
Also called Giraffe GELV61778 General Electric Company
We weaned the infants into two groups. Group A, 1.6 kg
Weaning from incubatorDevice
Also called Giraffe GELV61778 General Electric Company
We weaned the infants into two groups. group B, 1.4 kg
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | study group will be shifted from incubator to an unheated open cot a weight of 1400 grams Receives: Device: Weaning to crib; Device: Weaning from incubator |
| control group | Active comparator | control group will be shifted from incubator to an unheated open cot at a weight of 1600 grams Receives: Device: Weaning to crib; Device: Weaning from incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily weight gain
newborns were weighed naked daily as a routine NICU practice using electronic scales. The rate of weight gain was calculated as grams/kilogram per day over the week before and after transfer.
Measured: 1 month
temperature control
Hourly axillary temperature was taken until two consecutive readings of between 36.4 and 37.1 C, after which temperatures were taken 3 times with each feed until at least 72 hours after transfer and after that a minimum of four times a day until discharge. If the axillary temperature is less than 36.4◦C, an additional wrap was added. If the temperature remained low, an hour later, the newborn was returned to an incubator. Failure to transfer was defined as the inability to maintained body temperatures in a cot despite additional covering, with two consecutive axillary temperatures below 36.4 ◦C, one hour apart. If the temperature more than 37.1C°, the wraps were reduced accordingly.temperature
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start16 Apr 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdulrahman Al-Matary, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351425
- Sponsor's protocol ID
- 17-048
- Status last verified
- Apr 2020
- First submitted
- 18 Sep 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: If this study plan goes successfully through, we shall continue the study. Basically, there is no concern in regards to the safety of the participants
Publications
American Academy of Pediatrics Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008 Nov;122(5):1119-26. doi: 10.1542/peds.2008-2174.
PubMed 18977994Powell PJ, Powell CV, Hollis S, Robinson MJ. When will my baby go home? Arch Dis Child. 1992 Oct;67(10 Spec No):1214-6. doi: 10.1136/adc.67.10_spec_no.1214.
PubMed 1444564Brooten D, Kumar S, Brown LP, Butts P, Finkler SA, Bakewell-Sachs S, Gibbons A, Delivoria-Papadopoulos M. A randomized clinical trial of early hospital discharge and home follow-up of very-low-birth-weight infants. N Engl J Med. 1986 Oct 9;315(15):934-9. doi: 10.1056/NEJM198610093151505.
PubMed 3531852Casiro OG, McKenzie ME, McFadyen L, Shapiro C, Seshia MM, MacDonald N, Moffatt M, Cheang MS. Earlier discharge with community-based intervention for low birth weight infants: a randomized trial. Pediatrics. 1993 Jul;92(1):128-34.
PubMed 8390644Niknajad A, Ghojazadeh M, Sattarzadeh N, Bashar Hashemi F, Dezham Khoy Shahgholi F. Factors affecting the neonatal intensive care unit stay duration in very low birth weight premature infants. J Caring Sci. 2012 May 27;1(2):85-92. doi: 10.5681/jcs.2012.013. eCollection 2012 Jun.
PubMed 25276681Glass L, Silverman WA, Sinclair JC. Relationship of thermal environment and caloric intake to growth and resting metabolism in the late neonatal period. Biol Neonat. 1969;14(5):324-40. doi: 10.1159/000240198. No abstract available.
PubMed 4192368Gibson E, Medoff-Cooper B, Nuamah IF, Gerdes J, Kirkby S, Greenspan J. Accelerated discharge of low birth weight infants from neonatal intensive care: a randomized, controlled trial. The Early Discharge Study Group. J Perinatol. 1998 Nov-Dec;18(6 Pt 2 Su):S17-23. No abstract available.
PubMed 10023375New K, Bogossian F, East C, Davies MW. Practice variation in the transfer of premature infants from incubators to open cots in Australian and New Zealand neonatal nurseries: results of an electronic survey. Int J Nurs Stud. 2010 Jun;47(6):678-87. doi: 10.1016/j.ijnurstu.2009.10.017. Epub 2009 Nov 27.
PubMed 19945108Sutter TW, Phan D, Pierchala CE, Rishel W. Weaning of premature infants from the incubator to an open crib. J Perinatol. 1988 Summer;8(3):193-8.
PubMed 3225660New K, Flenady V, Davies MW. Transfer of preterm infants from incubator to open cot at lower versus higher body weight. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004214. doi: 10.1002/14651858.CD004214.pub4.
PubMed 21901688Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15.
PubMed 30337189Medoff-Cooper B. Transition of the preterm infant to an open crib. J Obstet Gynecol Neonatal Nurs. 1994 May;23(4):329-35. doi: 10.1111/j.1552-6909.1994.tb01884.x.
PubMed 8057186West CR, Williams M, Weston PJ. Feasibility and safety of early transfer of premature infants from incubators to cots: a pilot study. J Paediatr Child Health. 2005 Dec;41(12):659-62. doi: 10.1111/j.1440-1754.2005.00754.x.
PubMed 16398870Zecca E, Corsello M, Priolo F, Tiberi E, Barone G, Romagnoli C. Early weaning from incubator and early discharge of preterm infants: randomized clinical trial. Pediatrics. 2010 Sep;126(3):e651-6. doi: 10.1542/peds.2009-3005. Epub 2010 Aug 9.
PubMed 20696729Whyte RK. Neonatal management and safe discharge of late and moderate preterm infants. Semin Fetal Neonatal Med. 2012 Jun;17(3):153-8. doi: 10.1016/j.siny.2012.02.004. Epub 2012 Feb 24.
PubMed 22364676
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Earlier Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams
- ClinicalTrials.gov ID
- NCT04351425
- Acronym / sponsor ID
- 17-048
- Keywords
- Preterm, Patient discharge, Length of stay, Low birth weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 16 Apr 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 Apr 2020 (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.
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.
Detailed description
- Introduction To discharge a preterm newborn after staying in neonatal intensive care unit (NICU) is a multifactorial decision. According to the American Academy of pediatrics guidelines of the physiologic competencies for hospital discharge of the high-risk neonate including preterm ones, are sufficient oral feeding and mature respiratory control, and finally the ability to maintain a normal body temperature in an unheated open bed (1). These mostly are achieved between 36 and 37 weeks' postmenstrual age (2-4). Shortening the period of a hospital stay, it could be beneficial to decrease the emotional stress resulted from the separation between the mother and the newborn and parents; furthermore, it may reduce the hospital-acquired co-morbidities as sepsis and surgical needs (5) and accordingly reduce the economic burden on the society. The timing to wean from the incubator is crucial since the immaturity of preterm newborn's thermoregulatory mechanisms which could affect weight gain as an attempt to maintain body temperature, achieving full feeding volume, and as a result could delay discharge from hospital (6, 7). The target weight for incubator weaning varies widely among NICUs. The common usual practice is between of 1700-1800 g, and it is generally based on the professional experience and judgment (8, 9). In 2010, a Cochrane Review assessed transferring preterm infants from incubator to open bed at a lower body weight (˂1700 g) by comparing to a higher body weight (˃ 1700 g). The review showed that preterm newborns can be transferred to open beds at 1600 g without adverse effects on temperature stability in terms of return to incubator or daily weight gain (10). A multicenter trial achieved the same result (11). Moreover, there are few studies showed that infants can be successfully transferred into cots at weights down to 1500 g (9, 12). A pilot study carried out stepwise four cohort trials of newborn's transfer from incubators to open beds at 1800 g, then at 1700 g, then at 1600 g and then finally at 1500 g (13). It demonstrated that there were no significant differences between the four cohorts in maintain body temperature after incubator weaning. The primary outcome of this study was to evaluate the feasibility and safety of incubator weaning for medically stable preterm neonates to unheated open cot at a body weight of 1400 g in terms of daily weight gain and temperature control. Newborns in the same study period were compared to a control group weaned at body weight of 1600 g.
- Subjects and Methods:
2.1. Study design A prospective randomized clinical trial was conducted at NICU at King Fahad Medical City, Riyadh, Saudi Arabia. Preterm newborns admitted to NICU fulfilling items in inclusion and exclusion criteria during the period from August 2017 to October 2018 were included into the study.
All eligible newborns were randomized into two groups to be weaned at 1,400 or at 1,600 g in a 1:1 ratio, using random block of 4. Newborns were eligible if body weight less than 1400 g, they were at least 5 days of age at the time of transferring to cot, they fed at least 60 ml/kg/day at the time of transferring to cot, and they are medically stable with no significant apnea or bradycardia, no ventilator support, no phototherapy and not having a major congenital abnormality. Newborns were excluded if they didn't fulfill the above criteria or unlikely to reach the target weight within 7 days.
2.2. Procedures Nursery temperatures were adjusted at 24-28 ◦c from birth to cot. The subjects were dressed in a hat, one vest and two wraps. Then, they were randomly assigned to either study group or control group. Infants were weighed naked daily. In the study group, the newborns were transferred to cot at a weight of 1400 to 1499 g and in the control group; they were transferred at a weight of 1600 to 1699 g. In the first day in the open cot, they were not bathed.
2.3. Data Collected
- Baseline characteristics as birth weight, gestational age (GA), gender, age in days in the transfer day, body weight and GA in the transfer day.
- Relevant data from to incubator weaning
- After transfer, hourly axillary temperatures were taken until two consecutive readings between 36.4 and 37.1 °C. Then, temperatures were taken every 3 hours with each feed for at least 72 hours. After that, temperatures were taken four times a day minimum until discharge. If the axillary temperature was ˂36.4°C, thus an additional wrap was added. If the temperature was still low for an hour later, then the infant was returned to the incubator. Meanwhile, if the temperature was more than 37.1°C, a wrap was reduced.
- No of infants who failed to be transferred to cot. Failure of transfer is defined as the inability to maintained body temperatures above 36.4°C in a two consecutive axillary temperatures in a cot despite of adding covering.
- For infants who remained in an open crib, the rate of weight gain calculated every day over the week before and after transfer. In the discharge day, age in days after transfer to discharge date, WT and GA.
2.4. Statistical methodology: Data were statistically described in terms of mean ± SD for continuous data and in frequencies (number of cases). For comparative purposes between groups in all continuous data, independent t-test or Mann Whitney t test was adopted. X2-square and fisher test were used for assessing association in categorical data.. P values less than 0.05 were considered statistically significant. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 21 for Microsoft Windows.
2.5. Ethical considerations: Due to safety concerns, the study was carried out in two steps. Initially, we started infants' weaning with the approved weaning weight at1500 grams. A total of 19 preterm infants were randomized in two groups. Both groups were weaned to cot with a 100% success rate without any complications. Afterwards, the study was approved by the local Ethics Committee to start the second phase of the study at weaning weight of 1400 g. The parents were all directly contacted and agreed in writing informed consent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Weaning to crib, Device: Weaning from incubatorstudy group will be shifted from incubator to an unheated open cot a weight of 1400 grams |
| control group | Active comparator | Device: Weaning to crib, Device: Weaning from incubatorcontrol group will be shifted from incubator to an unheated open cot at a weight of 1600 grams |
Who may qualify
- Ages
- 23 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical weight less than 1.5 kg at birth
- Clinically stable
- No cardio or respiratory support
- Reached 2/3 of his/her enteral feeding
Key exclusion criteria (4 listed)
- IUGR
- Clinical unstable
- On cardio or respiratory support
- Dysmorphic
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 |
|---|---|---|
| Weaning to cribAlso: Giraffe GELV61778 General Electric CompanyWe weaned the infants into two groups. Group A, 1.6 kg | Device | control group, study group |
| Weaning from incubatorAlso: Giraffe GELV61778 General Electric CompanyWe weaned the infants into two groups. group B, 1.4 kg | Device | control group, study group |
Primary outcome
daily weight gain
Time frame: 1 month
newborns were weighed naked daily as a routine NICU practice using electronic scales. The rate of weight gain was calculated as grams/kilogram per day over the week before and after transfer.
temperature control
Time frame: 1 month
Hourly axillary temperature was taken until two consecutive readings of between 36.4 and 37.1 C, after which temperatures were taken 3 times with each feed until at least 72 hours after transfer and after that a minimum of four times a day until discharge. If the axillary temperature is less than 36.4◦C, an additional wrap was added. If the temperature remained low, an hour later, the newborn was returned to an incubator. Failure to transfer was defined as the inability to maintained body temperatures in a cot despite additional covering, with two consecutive axillary temperatures below 36.4 ◦C, one hour apart. If the temperature more than 37.1C°, the wraps were reduced accordingly.temperature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 18977994American Academy of Pediatrics Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008 Nov;122(5):1119-26. doi: 10.1542/peds.2008-2174.
- Background: PubMed 1444564Powell PJ, Powell CV, Hollis S, Robinson MJ. When will my baby go home? Arch Dis Child. 1992 Oct;67(10 Spec No):1214-6. doi: 10.1136/adc.67.10_spec_no.1214.
- Background: PubMed 3531852Brooten D, Kumar S, Brown LP, Butts P, Finkler SA, Bakewell-Sachs S, Gibbons A, Delivoria-Papadopoulos M. A randomized clinical trial of early hospital discharge and home follow-up of very-low-birth-weight infants. N Engl J Med. 1986 Oct 9;315(15):934-9. doi: 10.1056/NEJM198610093151505.
- Background: PubMed 8390644Casiro OG, McKenzie ME, McFadyen L, Shapiro C, Seshia MM, MacDonald N, Moffatt M, Cheang MS. Earlier discharge with community-based intervention for low birth weight infants: a randomized trial. Pediatrics. 1993 Jul;92(1):128-34.
- Background: PubMed 25276681Niknajad A, Ghojazadeh M, Sattarzadeh N, Bashar Hashemi F, Dezham Khoy Shahgholi F. Factors affecting the neonatal intensive care unit stay duration in very low birth weight premature infants. J Caring Sci. 2012 May 27;1(2):85-92. doi: 10.5681/jcs.2012.013. eCollection 2012 Jun.
- Background: PubMed 4192368Glass L, Silverman WA, Sinclair JC. Relationship of thermal environment and caloric intake to growth and resting metabolism in the late neonatal period. Biol Neonat. 1969;14(5):324-40. doi: 10.1159/000240198. No abstract available.
- Background: PubMed 10023375Gibson E, Medoff-Cooper B, Nuamah IF, Gerdes J, Kirkby S, Greenspan J. Accelerated discharge of low birth weight infants from neonatal intensive care: a randomized, controlled trial. The Early Discharge Study Group. J Perinatol. 1998 Nov-Dec;18(6 Pt 2 Su):S17-23. No abstract available.
- Background: PubMed 19945108New K, Bogossian F, East C, Davies MW. Practice variation in the transfer of premature infants from incubators to open cots in Australian and New Zealand neonatal nurseries: results of an electronic survey. Int J Nurs Stud. 2010 Jun;47(6):678-87. doi: 10.1016/j.ijnurstu.2009.10.017. Epub 2009 Nov 27.
- Background: PubMed 3225660Sutter TW, Phan D, Pierchala CE, Rishel W. Weaning of premature infants from the incubator to an open crib. J Perinatol. 1988 Summer;8(3):193-8.
- Background: PubMed 21901688New K, Flenady V, Davies MW. Transfer of preterm infants from incubator to open cot at lower versus higher body weight. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004214. doi: 10.1002/14651858.CD004214.pub4.
- Background: PubMed 30337189Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15.
- Background: PubMed 8057186Medoff-Cooper B. Transition of the preterm infant to an open crib. J Obstet Gynecol Neonatal Nurs. 1994 May;23(4):329-35. doi: 10.1111/j.1552-6909.1994.tb01884.x.
- Individual participant dataSharing planned: No. If this study plan goes successfully through, we shall continue the study. Basically, there is no concern in regards to the safety of the participants
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Weaning to crib and Weaning from incubator in people with Pre-Term and Body Temperature Changes, run by King Fahad Medical City.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulraham AM Al-Matary, MD (00966500333362, aalmatary@kfmc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily weight gain (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT04351425, which also lists 18 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 17 Apr 2020.