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Completed

NCT Number: NCT02160002

Incubator Weaning of Moderately Preterm Infants

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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Key information

Conditions

Infant, Newborn Infant, Moderate Preterm

Age range

29 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weaning from an incubator at a lower weight (1600 grams)

Procedure

Infants will be weaned from an incubator at a lower weight (1600 grams)

Weaning from an incubator at a higher weight (1800 grams)

Procedure

Infants will be weaned from an incubator at a higher weight (1800 grams)

Primary outcomes

  1. Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)

    Time frame: From birth through discharge

    Number of days the infant stays in hospital after birth until discharge home (up to 120 days).

Secondary outcomes

  1. Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)

    Time frame: 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).

  2. Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)

    Time frame: 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.

  3. Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)

    Time frame: 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).

  4. Growth Parameters: Weight at Status

    Time frame: 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.

  5. Growth Parameters: Length at Status

    Time frame: 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.

  6. Growth Parameters: Head Circumference at Status

    Time frame: 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.

  7. Postmenstrual Age (PMA) at Discharge

    Time frame: 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.

  8. Readmission to the Hospital Within 1 Week of Discharge

    Time frame: Discharge through 1 week after discharge.

    Number of infants re-hospitalized within 1 week (7 days) of discharge.

  9. Death Among Enrolled Infants

    Time frame: Status (discharge, death, transfer to another facility, or 120 days)

  10. Transferred to a Non-Network Hospital

    Time frame: Status (discharge, death, transfer to another facility, or 120 days)

    Number of infants transferred to another non-Network hospital.

  11. Length of Stay (LOS) Following Randomization to Hospital Discharge

    Time frame: From randomization through discharge.

    The number of days the infant stayed in hospital after randomization to the study until discharge.

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 10, 2014
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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