Infant, Moderate Preterm, Infant, Newborn
Conditions
Keywords
Incubator Weaning, Moderately Preterm Infants, Growth Velocity
Brief summary
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.
Interventions
PROCEDUREWeaning from an incubator at a lower weight (1600 grams)
Infants will be weaned from an incubator at a lower weight (1600 grams)
PROCEDUREWeaning from an incubator at a higher weight (1800 grams)
Infants will be weaned from an incubator at a higher weight (1800 grams)
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD Neonatal Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Weeks to 34 Weeks
Healthy volunteers
No
Inclusion criteria
* Gestational age 29 0/7 to 33 6/7 weeks at birth * Birth weight less than 1600 grams * Greater than 48 hours of age * Current weight less than 1540 grams * In an incubator
Exclusion criteria
* Receiving phototherapy * Receiving respiratory support (including CPAP, ventilation, HFNC \> 2 LPM) * Receiving blood pressure support * Designated for transfer to referral hospital while in incubator * Known major congenital or chromosomal anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) | From birth through discharge | Number of days the infant stays in hospital after birth until discharge home (up to 120 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) | From start of weaning from the incubator to crib through 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). |
| Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) | Through completion of 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. |
| Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) | Start of weaning from incubator through 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). |
| Growth Parameters: Weight at Status | Status (discharge, death, transfer to another facility, or 120 days) | Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days. |
| Growth Parameters: Length at Status | Status (discharge, death, transfer to another facility, or 120 days) | Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days. |
| Postmenstrual Age (PMA) at Discharge | 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. |
| Readmission to the Hospital Within 1 Week of Discharge | Discharge through 1 week after discharge. | Number of infants re-hospitalized within 1 week (7 days) of discharge. |
| Death Among Enrolled Infants | Status (discharge, death, transfer to another facility, or 120 days) | — |
| Transferred to a Non-Network Hospital | Status (discharge, death, transfer to another facility, or 120 days) | Number of infants transferred to another non-Network hospital. |
| Length of Stay (LOS) Following Randomization to Hospital Discharge | From randomization through discharge. | The number of days the infant stayed in hospital after randomization to the study until discharge. |
| Growth Parameters: Head Circumference at Status | Status (discharge, death, transfer to another facility, or 120 days) | Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Lower Weight (1600 Grams) Weaning from an incubator at a lower weight (1600 grams) | 187 |
| Higher Weight (1800 Grams) Weaning from an incubator at a higher weight (1800 grams) | 179 |
| Total | 366 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Lower Weight (1600 Grams) | Higher Weight (1800 Grams) | Total |
|---|---|---|---|
| Age, Customized Gestational Age | 31.2 weeks STANDARD_DEVIATION 1.3 | 31.1 weeks STANDARD_DEVIATION 1.2 | 31.1 weeks STANDARD_DEVIATION 1.2 |
| Cesarean Delivery | 136 Participants | 122 Participants | 258 Participants |
| Maternal Age | 28.8 years STANDARD_DEVIATION 5.8 | 28.9 years STANDARD_DEVIATION 6.1 | 28.8 years STANDARD_DEVIATION 5.9 |
| Postmenstrual (PMA) age at start of weaning | 33.8 weeks STANDARD_DEVIATION 1.3 | 34.3 weeks STANDARD_DEVIATION 1.2 | 34.1 weeks STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Black | 76 Participants | 72 Participants | 148 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 10 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 99 Participants | 97 Participants | 196 Participants |
| Sex: Female, Male Female | 93 Participants | 87 Participants | 180 Participants |
| Sex: Female, Male Male | 94 Participants | 92 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 187 | 0 / 179 |
| other Total, other adverse events | 19 / 187 | 7 / 179 |
| serious Total, serious adverse events | 1 / 187 | 0 / 179 |
Outcome results
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).
Time frame: From birth through discharge
Population: 185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Weight (1600 Grams) | Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) | 43 days |
| Higher Weight (1800 Grams) | Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) | 41 days |
Secondary
Death Among Enrolled Infants
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lower Weight (1600 Grams) | Death Among Enrolled Infants | 0 Participants |
| Higher Weight (1800 Grams) | Death Among Enrolled Infants | 0 Participants |
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.
Time frame: Through completion of 2 weaning attempts
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lower Weight (1600 Grams) | Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) | 15 Participants |
| Higher Weight (1800 Grams) | Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) | 8 Participants |
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.
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Population: 182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Weight (1600 Grams) | Growth Parameters: Head Circumference at Status | 31.9 centimeters | Standard Deviation 2.2 |
| Higher Weight (1800 Grams) | Growth Parameters: Head Circumference at Status | 32.0 centimeters | Standard Deviation 2 |
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.
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Population: 174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Weight (1600 Grams) | Growth Parameters: Length at Status | 44.6 centimeters | Standard Deviation 3.2 |
| Higher Weight (1800 Grams) | Growth Parameters: Length at Status | 44.9 centimeters | Standard Deviation 2.9 |
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.
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Population: 185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Weight (1600 Grams) | Growth Parameters: Weight at Status | 2336.3 grams | Standard Deviation 648 |
| Higher Weight (1800 Grams) | Growth Parameters: Weight at Status | 2353.6 grams | Standard Deviation 522 |
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).
Time frame: Start of weaning from incubator through 36 weeks postmenstrual age (PMA)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Weight (1600 Grams) | Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) | 15.8 grams/kilograms/day | Standard Deviation 4.8 |
| Higher Weight (1800 Grams) | Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) | 15.8 grams/kilograms/day | Standard Deviation 4.1 |
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.
Time frame: From randomization through discharge.
Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Weight (1600 Grams) | Length of Stay (LOS) Following Randomization to Hospital Discharge | 28 days |
| Higher Weight (1800 Grams) | Length of Stay (LOS) Following Randomization to Hospital Discharge | 27.5 days |
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).
Time frame: From start of weaning from the incubator to crib through discharge (up to 120 days)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Weight (1600 Grams) | Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) | 24 days |
| Higher Weight (1800 Grams) | Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) | 19 days |
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.
Time frame: Discharge
Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Weight (1600 Grams) | Postmenstrual Age (PMA) at Discharge | 37.1 weeks |
| Higher Weight (1800 Grams) | Postmenstrual Age (PMA) at Discharge | 37.0 weeks |
Secondary
Readmission to the Hospital Within 1 Week of Discharge
Number of infants re-hospitalized within 1 week (7 days) of discharge.
Time frame: Discharge through 1 week after discharge.
Population: 174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lower Weight (1600 Grams) | Readmission to the Hospital Within 1 Week of Discharge | 6 Participants |
| Higher Weight (1800 Grams) | Readmission to the Hospital Within 1 Week of Discharge | 2 Participants |
Secondary
Transferred to a Non-Network Hospital
Number of infants transferred to another non-Network hospital.
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lower Weight (1600 Grams) | Transferred to a Non-Network Hospital | 11 Participants |
| Higher Weight (1800 Grams) | Transferred to a Non-Network Hospital | 9 Participants |
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).
Time frame: 24 hours after successful wean to 36 weeks postmenstrual age (PMA)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Weight (1600 Grams) | Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA) | 11.0 grams/kilograms/day | Standard Deviation 7.4 |
| Higher Weight (1800 Grams) | Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA) | 9.6 grams/kilograms/day | Standard Deviation 7 |