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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Weight (1600 grams) | Active Comparator | Weaning from an incubator at a lower weight (1600 grams) |
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| Higher Weight (1800 grams) | Active Comparator | Weaning from an incubator at a higher weight (1800 grams) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weaning from an incubator at a lower weight (1600 grams) | Procedure | Infants will be weaned from an incubator at a lower weight (1600 grams) |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) | Number of days the infant stays in hospital after birth until discharge home (up to 120 days). | From birth through discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) | Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days). | From start of weaning from the incubator to crib through discharge (up to 120 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele C Walsh, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | Principal Investigator |
| Myra Wyckoff, MD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Study Chair |
| David Carlton, MD | Emory University | Principal Investigator |
| Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Brenda B Poindexter, MD | Indiana University | Principal Investigator |
| Abbot Laptook, MD | Brown University, Women & Infants Hosptial of Rhode Island | Principal Investigator |
| Krisa P Van Meurs, MD | Stanford University | Principal Investigator |
| Waldemar Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California - Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31033050 | Derived | Chowdhary V, Shukla A. Weaning of moderately preterm infants from the incubator to the crib: a randomized clinical trial. Acta Paediatr. 2019 Jul;108(7):1364. doi: 10.1111/apa.14774. Epub 2019 Apr 29. No abstract available. | |
| 30337189 | Derived | Shankaran 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. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network site | View source |
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1565 infants were screened for eligibility. 1199 infants were excluded. 680 were excluded due to not meeting all eligibility conditions, 510 did not get consent for randomization, and 9 were consented but not randomized due to parent (1 infant) or doctor withdrawal (1 infant), becoming medically unstable (3 infants) or other reasons (4 infants).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lower Weight (1600 Grams) | Weaning from an incubator at a lower weight (1600 grams) |
| FG001 | Higher Weight (1800 Grams) | Weaning from an incubator at a higher weight (1800 grams) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Weaning from an incubator at a higher weight (1800 grams) | Procedure | Infants will be weaned from an incubator at a higher weight (1800 grams) |
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| Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) | Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings. | Through completion of 2 weaning attempts |
| Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) | Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA). | Start of weaning from incubator through 36 weeks postmenstrual age (PMA) |
| Growth Parameters: Weight at Status | Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days. | Status (discharge, death, transfer to another facility, or 120 days) |
| Growth Parameters: Length at Status | Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days. | Status (discharge, death, transfer to another facility, or 120 days) |
| Growth Parameters: Head Circumference at Status | Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days. | Status (discharge, death, transfer to another facility, or 120 days) |
| Postmenstrual Age (PMA) at Discharge | Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge. | Discharge |
| Readmission to the Hospital Within 1 Week of Discharge | Number of infants re-hospitalized within 1 week (7 days) of discharge. | Discharge through 1 week after discharge. |
| Death Among Enrolled Infants | Status (discharge, death, transfer to another facility, or 120 days) |
| Transferred to a Non-Network Hospital | Number of infants transferred to another non-Network hospital. | Status (discharge, death, transfer to another facility, or 120 days) |
| Length of Stay (LOS) Following Randomization to Hospital Discharge | The number of days the infant stayed in hospital after randomization to the study until discharge. | From randomization through discharge. |
| Kathleen A Kennedy, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Mike Cotten, MD | Duke University | Principal Investigator |
| Edward F Bell, MD | University of Iowa | Principal Investigator |
| Kristi Watterberg, MD | University of New Mexico | Principal Investigator |
| Barbara Schmidt, MD | University of Pennsylvania | Principal Investigator |
| Carl T D'Angio, MD | University of Rochester | Principal Investigator |
| Uday Devaskar, MD | University of California, Los Angeles | Principal Investigator |
| Pablo Sanchez, MD | Research Institute at Nationwide Children's Hospital | Principal Investigator |
| William Truog, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Abhik Das, PhD | RTI International | Principal Investigator |
| Los Angeles |
| California |
| 90025 |
| United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Univeristy of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| NICHD Pregnancy \& Perinatology Branch | View source |
| Primary Outcome |
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| COMPLETED |
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| NOT COMPLETED |
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A total of 366 infants were randomized in the study. 187 infants were randomized to the Lower Weight group. 179 infants were randomized to the Higher Weight group. The baseline statistics are based on the number of mothers or infants for whom data were available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lower Weight (1600 Grams) | Weaning from an incubator at a lower weight (1600 grams) |
| BG001 | Higher Weight (1800 Grams) | Weaning from an incubator at a higher weight (1800 grams) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Postmenstrual (PMA) age at start of weaning | Mean | Standard Deviation | weeks |
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| Maternal Age | Mean | Standard Deviation | years |
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| Cesarean Delivery | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) | Number of days the infant stays in hospital after birth until discharge home (up to 120 days). | 185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available. | Posted | Median | Inter-Quartile Range | days | From birth through discharge |
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| Secondary | Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) | Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days). | There were 163 infants in the Lower Weight group that were successfully weaned from incubator to the crib; discharge date was missing for one of these infants. There were 159 infants in the Higher Weight group that were successfully weaned from incubator to the crib; 4 infants were missing start of weaning dates because of protocol violations. | Posted | Median | Inter-Quartile Range | days | From start of weaning from the incubator to crib through discharge (up to 120 days) |
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| Secondary | Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) | Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings. | 178 infants in the Lower Weight group and 167 infants in the Higher Weight group have the data on whether weaning from incubator to crib was successful after two attempts at weaning. | Posted | Count of Participants | Participants | Through completion of 2 weaning attempts |
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| Secondary | Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) | Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA). | There were 257 (136 LW and 121 HW) infants who remained in the hospital at 36 weeks PMA that have weights measured at 36 weeks PMA. Twenty six infants (10 LW and 16 HW) who were still in the incubator at 36 weeks PMA and 20 infants (7 LW and 13 HW) missing the date of start of weaning were excluded from the analysis. | Posted | Mean | Standard Deviation | grams/kilograms/day | Start of weaning from incubator through 36 weeks postmenstrual age (PMA) |
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| Secondary | Growth Parameters: Weight at Status | Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days. | 185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status. | Posted | Mean | Standard Deviation | grams | Status (discharge, death, transfer to another facility, or 120 days) |
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| Secondary | Growth Parameters: Length at Status | Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days. | 174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data. | Posted | Mean | Standard Deviation | centimeters | Status (discharge, death, transfer to another facility, or 120 days) |
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| Secondary | Growth Parameters: Head Circumference at Status | Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days. | 182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data. | Posted | Mean | Standard Deviation | centimeters | Status (discharge, death, transfer to another facility, or 120 days) |
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| Secondary | Postmenstrual Age (PMA) at Discharge | Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge. | 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data. | Posted | Median | Inter-Quartile Range | weeks | Discharge |
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| Secondary | Readmission to the Hospital Within 1 Week of Discharge | Number of infants re-hospitalized within 1 week (7 days) of discharge. | 174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up. | Posted | Count of Participants | Participants | Discharge through 1 week after discharge. |
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| Secondary | Death Among Enrolled Infants | 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data. | Posted | Count of Participants | Participants | Status (discharge, death, transfer to another facility, or 120 days) |
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| Secondary | Transferred to a Non-Network Hospital | Number of infants transferred to another non-Network hospital. | 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data. | Posted | Count of Participants | Participants | Status (discharge, death, transfer to another facility, or 120 days) |
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| Secondary | Length of Stay (LOS) Following Randomization to Hospital Discharge | The number of days the infant stayed in hospital after randomization to the study until discharge. | 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge. | Posted | Median | Inter-Quartile Range | days | From randomization through discharge. |
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| Post-Hoc | Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA) | Growth velocity in terms of weight (g/kg/day), considering infant weight at 24 hours after successful wean to crib and weight at 36 weeks postmenstrual age (PMA). | 257 infants (136 LW, 121 HW) remained in hospital at 36 weeks PMA w/ weight measured at 36 weeks PMA. 26 (10 LW, 16 HW) were still in incubator at 36 weeks PMA, 31 (16 LW, 15 HW) were missing weight after 24 hrs of successful wean, and 4 (LW) w/ weights measured at 24 hrs after successful wean were missing date of 24 hr weight after successful wean | Posted | Mean | Standard Deviation | grams/kilograms/day | 24 hours after successful wean to 36 weeks postmenstrual age (PMA) |
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Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure.
Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lower Weight (1600 Grams) | Weaning from an incubator at a lower weight (1600 grams) | 0 | 187 | 1 | 187 | 19 | 187 |
| EG001 | Higher Weight (1800 Grams) | Weaning from an incubator at a higher weight (1800 grams) | 0 | 179 | 0 | 179 | 7 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Pneumoperitoneum | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Moderate cold stress | Metabolism and nutrition disorders | Systematic Assessment |
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| Severe cold stress | Metabolism and nutrition disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Feeding Intolerance | Gastrointestinal disorders | Systematic Assessment |
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| Desaturations | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| NEC IIa | Gastrointestinal disorders | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tachycardia with desaturations | Cardiac disorders | Systematic Assessment |
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| Increasing heart failure | Cardiac disorders | Systematic Assessment |
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Investigators must adhere to the Neonatal Research Network Publication policies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seetha Shankaran | Wayne State University | (313) 745-1436 | sshankar@med.wayne.edu |
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