Premature NeonatesNCT00769262
Weaning Thermoregulatory Support in Preterm Neonates
A study testing Conservative weaning and Aggressive Weaning in people with Premature Neonates, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Preterm newborns typically must be thermally regulated. In the United States, isolettes (incubators) are used to help them maintain their temperature. Traditionally, the temperature support (i.e. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Premature Neonates
- What is being tested?
- Conservative weaning and Aggressive Weaning
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2008to 26 Jan 2011
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Live born preterm infants from 26 and 0/7 weeks gestation to 34 and 6/7 weeks gestation
- Require thermoregulatory support
- Are able to take feeds
- Are presumed to be able to take oral feeds in the future
Who cannot join
- Preterm infants less than 26 and 0/7 weeks gestation
- Preterm infants greater than 34 and 6/7 weeks gestation
- Infants that do not require thermoregulatory support
- Infants that will not be able to have enteral feeds
- Infants with endocrine disease
- Infants with congenital anomalies
Show all 9Show fewer
- Infants with grade 3 or 4 intraventricular hemorrhage or other severe neurologic disability
- Infants requiring long-term sedation
- Infants that die within 7 days of birth
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Regional Hospital
Columbia, Missouri, 65201
About this study
Official title: Effect of Conservative Weaning of Thermoregulatory Support on Weight Gain and Length of Stay in Preterm Neonates
Preterm newborns typically must be thermally regulated. In the United States, isolettes (incubators) are used to help them maintain their temperature. Traditionally, the temperature support (i.e. the temperature of the incubator) is decreased slowly according to NICU protocol until the baby is able to maintain its temperature in an open crib, without regard to the status of its feedings. This study will attempt to determine if there is a difference in length of stay, weight gain, and calories needed to gain appropriate weight between a group of newborns whose isolette temperatures are decreased in an aggressive strategy (isolette temperatures are decreased based only on baby's body temperature), and a group of newborns whose isolette temperatures are decreased in a conservative strategy (isolette temperatures are decreased to a minimum temperature and then kept steady until their feeds are at caloric goal and they are taking at least half of their feeds by mouth).
Read the detailed description
General Background:
There are three key milestones premature infants must meet prior to discharge from the NICU:
- The ability to maintain their temperature in an open crib
- The ability to consume enough calories for adequate growth by oral feeds
- A demonstrated weight gain consuming these feeds.
It is well understood that infants must increase their resting metabolic rate when weaned from the isolette to an open crib (1, 6). Preterm neonates have less metabolic reserve (brown fat) to allow them to mount an appropriate thermogenic response to cold stress (4). The reserve they do have is often depleted at delivery, leaving them with little or no reserve (4). When a neonate is challenged to maintain its body temperature, it must increase heat production which may affect weight gain (3). Some institutions wean without regard to neonate's weight or feeding status, while others only begin the weaning process at a predetermined weight. Currently neonates are weaned from their isolettes based largely on the traditions and experiences of clinicians, without regard to their feeding status. However, there is currently very little evidence in the literature to inform practice on the ideal conditions for weaning a neonate from their isolette. An extensive literature review has revealed no published data regarding the relationship of feed status to success at isolette weaning.
The transfer to open crib is important; if the neonate is not able to maintain his/her temperature, the length of stay could be lengthened and weight gain adversely affected (3). Cold stress can also cause adverse clinical effects including lethargy, hypotonia, poor feeding, abdominal distention, vomiting, pallor, tachypnea, and respiratory distress (2). These adverse clinical effects may also lengthen cost and length of stay, as well as adversely affect feeding. Furthermore, a return to the isolette can be quite stressful to parents and family members (3).
Subjects:
Approximately 110 subjects will be recruited. The subjects for this study will be live born preterm infants between 26 and 0/7 weeks gestation and 34 and 6/7 weeks gestation. Informed consent will be obtained from the parents.
Methods:
Neonates will be randomly assigned to either the control group (with standard thermoregulatory weaning protocol) vs. experimental group (with conservative thermoregulatory weaning protocol). After an infant is enrolled in the study, an envelope indicating random assignment to either the aggressive or conservative group will be drawn and the infant will be assigned to the indicated study group. The envelopes will be provided by the statistician and will be delivered in groups of 10 to ensure relatively equal numbers of babies in both study groups.
All infants will be advanced to goal caloric feeds of 120 Kcal/kg. Weight gain will be measured biweekly, and if adequate weight gain (average 20 grams/kg/day) is not reached, feeds will be advanced by 10 Kcal/kg/day biweekly until adequate weight gain is reached.
All infants will be kept on skin control mode until they weigh 1500 grams. Babies on skin control mode will be unclothed except for a diaper. Once infants reach 1500 grams, they will be placed on air control mode. Babies on air control mode will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and no blankets or other clothing.
Control Group: Aggressive Wean
Weaning Process:
- If baby's temperature is greater than or equal to 36.7°C on 2 consecutive measurements 3 hours apart, the isolette set temperature will be lowered by 0.2°C.
- If baby's temperature is less than 36.3°C on 1 measurement, the isolette set temperature will be increased by 0.2°C.
- Once the baby's temperature is stable at greater than 36.7°C for 3 consecutive measurements 3 hours apart on an isolette set temp of 28.0°C, the baby will be transferred to an open crib. At this time, the baby will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and a sleep sack. NO heavy blankets (such as bath blankets) or extra blankets are to be used.
- If the baby's temperature is less than 36.3°C on 1 measurement, they will be transferred back to the isolette and the weaning process will begin again.
Experimental Group: Conservative Wean
Weaning Process:
- If baby's temperature is greater than or equal to 37.2°C on 2 consecutive measurements 3 hours apart, the isolette set temperature will be lowered by 0.2°C.
- If baby's temperature is less than 36.3°C on 1 measurement, the isolette set temperature will be increased by 0.2°C.
- Once the baby's temperature is stable at greater than 37.2°C for 3 consecutive measurements 3 hours apart on an isolette set temp of 28.0°C, AND the baby is taking full caloric need feeds (at least 120 Kcal/kg/day), AND the baby is taking half of its feeds by mouth the baby will be transferred to an open crib. At this time, the baby will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and a sleep sack. NO heavy blankets (such as bath blankets) or extra blankets are to be used.
- If the baby's temperature is stable at greater than 37.2°C for 4 consecutive measurements 3 hours apart on an isolette set temp of 28.0°C, or if the baby's temperature is greater than 37.9°C on an isolette set temp of 28.0°C, the baby will be transferred to an open crib regardless of feeding status. At this time, the baby will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and a sleep sack. NO heavy blankets (such as bath blankets) or extra blankets are to be used.
- If the baby's temperature is less than 36.3 degrees Celsius on 1 measurement, they will be transferred back to the isolette and the weaning process will begin again.
Research Significance and Future Research:
This study will provide data regarding the weaning of thermoregulatory support in preterm infants, and could have significant economic impact for the university if there is a significant difference in length of stay between the study groups. Future research will focus on long-term effects on outcomes such as nutritional status in infancy and BMI in childhood if neonates do require greater caloric intake if they are weaned from thermoregulatory support faster.
Bibliography:
- Dollberg S, Mimouni FB, Weintraub V. (2004) Energy expenditure in infants weaned from a convective incubator. American Journal of Perinatology. 21(5):253-6
- Hackman P. (2001) Recognizing and understanding the cold-stressed term infant. The Journal of Neonatal Nursing. 20(8):35-41
- New K, Flenady V, Davies MW. (2007) Transfer of preterm infants from incubator to open cot at lower versus higher body weight. The Cochrane Database of Systematic Reviews. 4.
- Sherman TI, Greenspan JS, St. Clair N, Touch S, Shaffer T. (2006) Optimizing the neonatal thermal environment. Neonatal Network; The Journal of Neonatal Nursing. 25(4):251-60
- Short MA. (1998) A comparison of temperature in VLBW infants swaddled versus unswaddled in a double-walled incubator in skin control mode. Neonatal Network; The Journal of Neonatal Nursing. 17(3):25-31
- Weintraub V, Mimouni FB, Dollberg S. (2007) Changes in energy expenditure in preterm infants during weaning: A randomized comparison of two weaning methods from an incubator. Pediatric Research. 61(3):341-4
- Conditions
- Premature Neonates
- Being tested
- Conservative weaning, Aggressive Weaning
- Keywords
- Premature neonates, Thermoregulation, Isolette, Feeding status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative weaningOther
Infants will not be weaned from the isolette until their feeds are at full calorie goal (120 kcal/kg/day) and at least half of feeds are taken orally.
Aggressive WeaningOther
Infants will be weaned from the isolette based solely on their temperature without regard to feed status (current standard of care in our NICU)
| Study group | Role | What they receive |
|---|---|---|
| Aggressive Weaning | Active comparator | Infants will be weaned from the isolette using our current NICU standard of care. Receives: Other: Aggressive Weaning |
| Conservative Weaning | Experimental | Infants will be weaned from the isolette using a modified conservative weaning schedule. Receives: Other: Conservative weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: Hospital discharge
Secondary outcomes (2)
Weight gain
Measured: When patient is on 120 cal/kg/day dietary intake
Caloric requirement
Measured: When patient is changed to oral ad lib demand feeds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study start22 Oct 2008
- Primary completion26 Jan 2011
- Study completion26 Jan 2011
Why it stopped: insufficient resources to conduct study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NeonatesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah B Patton, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769262
- Sponsor's protocol ID
- 1105137
- Status last verified
- May 2017
- First submitted
- 8 Oct 2008
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conservative Weaning of Thermoregulatory Support on Weight Gain and Length of Stay in Preterm Neonates
- ClinicalTrials.gov ID
- NCT00769262
- Acronym / sponsor ID
- 1105137
- Conditions
- Premature Neonates
- Keywords
- Premature neonates, Thermoregulation, Isolette, Feeding status
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient resources to conduct study
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 22 Oct 2008 (actual)
- Primary completion
- 26 Jan 2011 (actual)
- Study completion
- 26 Jan 2011 (actual)
- First posted
- 9 Oct 2008 (estimated)
- 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.
Preterm newborns typically must be thermally regulated. In the United States, isolettes (incubators) are used to help them maintain their temperature. Traditionally, the temperature support (i.e. the temperature of the incubator) is decreased slowly according to NICU protocol until the baby is able to maintain its temperature in an open crib, without regard to the status of its feedings. This study will attempt to determine if there is a difference in length of stay, weight gain, and calories needed to gain appropriate weight between a group of newborns whose isolette temperatures are decreased in an aggressive strategy (isolette temperatures are decreased based only on baby's body temperature), and a group of newborns whose isolette temperatures are decreased in a conservative strategy (isolette temperatures are decreased to a minimum temperature and then kept steady until their feeds are at caloric goal and they are taking at least half of their feeds by mouth).
Detailed description
General Background:
There are three key milestones premature infants must meet prior to discharge from the NICU:
- The ability to maintain their temperature in an open crib
- The ability to consume enough calories for adequate growth by oral feeds
- A demonstrated weight gain consuming these feeds.
It is well understood that infants must increase their resting metabolic rate when weaned from the isolette to an open crib (1, 6). Preterm neonates have less metabolic reserve (brown fat) to allow them to mount an appropriate thermogenic response to cold stress (4). The reserve they do have is often depleted at delivery, leaving them with little or no reserve (4). When a neonate is challenged to maintain its body temperature, it must increase heat production which may affect weight gain (3). Some institutions wean without regard to neonate's weight or feeding status, while others only begin the weaning process at a predetermined weight. Currently neonates are weaned from their isolettes based largely on the traditions and experiences of clinicians, without regard to their feeding status. However, there is currently very little evidence in the literature to inform practice on the ideal conditions for weaning a neonate from their isolette. An extensive literature review has revealed no published data regarding the relationship of feed status to success at isolette weaning.
The transfer to open crib is important; if the neonate is not able to maintain his/her temperature, the length of stay could be lengthened and weight gain adversely affected (3). Cold stress can also cause adverse clinical effects including lethargy, hypotonia, poor feeding, abdominal distention, vomiting, pallor, tachypnea, and respiratory distress (2). These adverse clinical effects may also lengthen cost and length of stay, as well as adversely affect feeding. Furthermore, a return to the isolette can be quite stressful to parents and family members (3).
Subjects:
Approximately 110 subjects will be recruited. The subjects for this study will be live born preterm infants between 26 and 0/7 weeks gestation and 34 and 6/7 weeks gestation. Informed consent will be obtained from the parents.
Methods:
Neonates will be randomly assigned to either the control group (with standard thermoregulatory weaning protocol) vs. experimental group (with conservative thermoregulatory weaning protocol). After an infant is enrolled in the study, an envelope indicating random assignment to either the aggressive or conservative group will be drawn and the infant will be assigned to the indicated study group. The envelopes will be provided by the statistician and will be delivered in groups of 10 to ensure relatively equal numbers of babies in both study groups.
All infants will be advanced to goal caloric feeds of 120 Kcal/kg. Weight gain will be measured biweekly, and if adequate weight gain (average 20 grams/kg/day) is not reached, feeds will be advanced by 10 Kcal/kg/day biweekly until adequate weight gain is reached.
All infants will be kept on skin control mode until they weigh 1500 grams. Babies on skin control mode will be unclothed except for a diaper. Once infants reach 1500 grams, they will be placed on air control mode. Babies on air control mode will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and no blankets or other clothing.
Control Group: Aggressive Wean
Weaning Process:
- If baby's temperature is greater than or equal to 36.7°C on 2 consecutive measurements 3 hours apart, the isolette set temperature will be lowered by 0.2°C.
- If baby's temperature is less than 36.3°C on 1 measurement, the isolette set temperature will be increased by 0.2°C.
- Once the baby's temperature is stable at greater than 36.7°C for 3 consecutive measurements 3 hours apart on an isolette set temp of 28.0°C, the baby will be transferred to an open crib. At this time, the baby will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and a sleep sack. NO heavy blankets (such as bath blankets) or extra blankets are to be used.
- If the baby's temperature is less than 36.3°C on 1 measurement, they will be transferred back to the isolette and the weaning process will begin again.
Experimental Group: Conservative Wean
Weaning Process:
- If baby's temperature is greater than or equal to 37.2°C on 2 consecutive measurements 3 hours apart, the isolette set temperature will be lowered by 0.2°C.
- If baby's temperature is less than 36.3°C on 1 measurement, the isolette set temperature will be increased by 0.2°C.
- Once the baby's temperature is stable at greater than 37.2°C for 3 consecutive measurements 3 hours apart on an isolette set temp of 28.0°C, AND the baby is taking full caloric need feeds (at least 120 Kcal/kg/day), AND the baby is taking half of its feeds by mouth the baby will be transferred to an open crib. At this time, the baby will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and a sleep sack. NO heavy blankets (such as bath blankets) or extra blankets are to be used.
- If the baby's temperature is stable at greater than 37.2°C for 4 consecutive measurements 3 hours apart on an isolette set temp of 28.0°C, or if the baby's temperature is greater than 37.9°C on an isolette set temp of 28.0°C, the baby will be transferred to an open crib regardless of feeding status. At this time, the baby will be dressed in one medium-weight sleeper with feet (or with socks if sleeper is footless), one hat, and a sleep sack. NO heavy blankets (such as bath blankets) or extra blankets are to be used.
- If the baby's temperature is less than 36.3 degrees Celsius on 1 measurement, they will be transferred back to the isolette and the weaning process will begin again.
Research Significance and Future Research:
This study will provide data regarding the weaning of thermoregulatory support in preterm infants, and could have significant economic impact for the university if there is a significant difference in length of stay between the study groups. Future research will focus on long-term effects on outcomes such as nutritional status in infancy and BMI in childhood if neonates do require greater caloric intake if they are weaned from thermoregulatory support faster.
Bibliography:
- Dollberg S, Mimouni FB, Weintraub V. (2004) Energy expenditure in infants weaned from a convective incubator. American Journal of Perinatology. 21(5):253-6
- Hackman P. (2001) Recognizing and understanding the cold-stressed term infant. The Journal of Neonatal Nursing. 20(8):35-41
- New K, Flenady V, Davies MW. (2007) Transfer of preterm infants from incubator to open cot at lower versus higher body weight. The Cochrane Database of Systematic Reviews. 4.
- Sherman TI, Greenspan JS, St. Clair N, Touch S, Shaffer T. (2006) Optimizing the neonatal thermal environment. Neonatal Network; The Journal of Neonatal Nursing. 25(4):251-60
- Short MA. (1998) A comparison of temperature in VLBW infants swaddled versus unswaddled in a double-walled incubator in skin control mode. Neonatal Network; The Journal of Neonatal Nursing. 17(3):25-31
- Weintraub V, Mimouni FB, Dollberg S. (2007) Changes in energy expenditure in preterm infants during weaning: A randomized comparison of two weaning methods from an incubator. Pediatric Research. 61(3):341-4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive Weaning | Active comparator | Other: Aggressive WeaningInfants will be weaned from the isolette using our current NICU standard of care. |
| Conservative Weaning | Experimental | Other: Conservative weaningInfants will be weaned from the isolette using a modified conservative weaning schedule. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Live born preterm infants from 26 and 0/7 weeks gestation to 34 and 6/7 weeks gestation
- Require thermoregulatory support
- Are able to take feeds
- Are presumed to be able to take oral feeds in the future
Key exclusion criteria (9 listed)
- Preterm infants less than 26 and 0/7 weeks gestation
- Preterm infants greater than 34 and 6/7 weeks gestation
- Infants that do not require thermoregulatory support
- Infants that will not be able to have enteral feeds
- Infants with endocrine disease
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 |
|---|---|---|
| Conservative weaningInfants will not be weaned from the isolette until their feeds are at full calorie goal (120 kcal/kg/day) and at least half of feeds are taken orally. | Other | Conservative Weaning |
| Aggressive WeaningInfants will be weaned from the isolette based solely on their temperature without regard to feed status (current standard of care in our NICU) | Other | Aggressive Weaning |
Primary outcome
Length of hospital stay
Time frame: Hospital discharge
2 secondary outcomes
Weight gain
Time frame: When patient is on 120 cal/kg/day dietary intake
Caloric requirement
Time frame: When patient is changed to oral ad lib demand feeds
Results and safety
The study was stopped early (reason given: insufficient resources to conduct study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Sarah B Patton, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative weaning and Aggressive Weaning in people with Premature Neonates, run by University of Missouri-Columbia at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: insufficient resources to conduct study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2017.