<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422041</url>
  </required_header>
  <id_info>
    <org_study_id>PE15-039</org_study_id>
    <nct_id>NCT04422041</nct_id>
  </id_info>
  <brief_title>Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns</brief_title>
  <official_title>Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Nuevo Leon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Nuevo Leon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compared hospital readmission and complications between very early discharge and&#xD;
      early discharge in healthy newborn patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction. Very early postnatal discharge is defined as a hospital stay of the&#xD;
      mother-child dyad of less than 24 hours. It is usually performed in public institutions of&#xD;
      low-income countries due to high birth rates; it has not been associated to a higher&#xD;
      proportion of neonatal admissions, however, very early discharge might increase this risk.&#xD;
      The objective of this study was to compare the rate hospital readmission in patients with&#xD;
      very early vs early postnatal discharge.&#xD;
&#xD;
      Methods A prospective, randomized clinical study was performed with healthy term infants born&#xD;
      in a hospital in Mexico from July 2016 to June 2018. Sample was randomized into two groups, a&#xD;
      very early discharge group (&lt;24 hours) and an early discharge group (24-48 hours). Hospital&#xD;
      readmission rate was analyzed in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">July 29, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>They were selected based on a random computer program in a 1: 1 model, assigning each subject randomly to one of the two study groups</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessors consisted of hospital staff not involved in the investigation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital readmission rate</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of participant newborns who were readmitted into the hospital during follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of attention in emergency services</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of participant newborns who attended the emergency services during follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate associated factors</measure>
    <time_frame>28 days</time_frame>
    <description>Statistical associations between the primary outcome and other variables of interest</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">354</enrollment>
  <condition>Hospital Readmission</condition>
  <condition>Newborn Morbidity</condition>
  <condition>Newborn Complication</condition>
  <condition>Newborn</condition>
  <arm_group>
    <arm_group_label>Early discharge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Discharge between 24 and 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Very early discharge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Discharge in less than 24 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Time to discharge less than 24 hours</intervention_name>
    <description>Allow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.</description>
    <arm_group_label>Very early discharge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discharge time between 24 and 48 hours</intervention_name>
    <description>Allow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.</description>
    <arm_group_label>Early discharge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy newborns that were born from vaginal delivery in primiparous or multiparous&#xD;
             women where both the mother and the newborn were deemed as eligible for early&#xD;
             discharge according to the American Association of Pediatrics criteria and by a&#xD;
             clinical obstetric mother evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Placenta praevia, abnormal bleeding during vaginal delivery (considered as greater&#xD;
             than 500mL), inhability to deambulate, medical complications from previous a previous&#xD;
             pregnancy, 3rd or 4th degree perineal laceration as well as medical conditions that&#xD;
             required any monitorization for more than 24 hours after delivery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>2 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erika Ochoa-Correa, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics</affiliation>
  </overall_official>
  <link>
    <url>http://www.cndh.org.mx/sites/all/doc/Programas/VIH/Leyes%20y%20normas%20y%20reglamentos/Norma%20Oficial%20Mexicana/NOM-007-SSA2-2016%20Embarazo,%20parto%20y%20puerperio.pdf</url>
    <description>Norma Oficial Mexicana NOM-007-SSA2-2016 para la atención de la mujer durante el embarazo, parto y puerperio, y de la persona recién nacida.</description>
  </link>
  <reference>
    <citation>Jones E, Taylor B, MacArthur C, Pritchett R, Cummins C. The effect of early postnatal discharge from hospital for women and infants: a systematic review protocol. Syst Rev. 2016 Feb 8;5:24. doi: 10.1186/s13643-016-0193-9.</citation>
    <PMID>26857705</PMID>
  </reference>
  <reference>
    <citation>Brown S, Small R, Faber B, Krastev A, Davis P. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2002;(3):CD002958. doi: 10.1002/14651858.CD002958.</citation>
    <PMID>12137666</PMID>
  </reference>
  <reference>
    <citation>Benitz WE; Committee on Fetus and Newborn, American Academy of Pediatrics. Hospital stay for healthy term newborn infants. Pediatrics. 2015 May;135(5):948-53. doi: 10.1542/peds.2015-0699.</citation>
    <PMID>25917993</PMID>
  </reference>
  <reference>
    <citation>Chalmers B, Mangiaterra V, Porter R. WHO principles of perinatal care: the essential antenatal, perinatal, and postpartum care course. Birth. 2001 Sep;28(3):202-7. doi: 10.1046/j.1523-536x.2001.00202.x.</citation>
    <PMID>11552969</PMID>
  </reference>
  <reference>
    <citation>Capurro H, Konichezky S, Fonseca D, Caldeyro-Barcia R. A simplified method for diagnosis of gestational age in the newborn infant. J Pediatr. 1978 Jul;93(1):120-2. doi: 10.1016/s0022-3476(78)80621-0. No abstract available.</citation>
    <PMID>650322</PMID>
  </reference>
  <reference>
    <citation>SILVERMAN WA, ANDERSEN DH. A controlled clinical trial of effects of water mist on obstructive respiratory signs, death rate and necropsy findings among premature infants. Pediatrics. 1956 Jan;17(1):1-10. No abstract available.</citation>
    <PMID>13353856</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Nuevo Leon</investigator_affiliation>
    <investigator_full_name>Erika Ochoa-Correa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Newborn Infant</keyword>
  <keyword>Hospital readmission</keyword>
  <keyword>Early discharge</keyword>
  <keyword>Very early discharge</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422041
org study id: PE15-039
nct id: NCT04422041
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compared hospital readmission and complications between very early discharge and
      early discharge in healthy newborn patients.
Introduction. Very early postnatal discharge is defined as a hospital stay of the
      mother-child dyad of less than 24 hours. It is usually performed in public institutions of
      low-income countries due to high birth rates; it has not been associated to a higher
      proportion of neonatal admissions, however, very early discharge might increase this risk.
      The objective of this study was to compare the rate hospital readmission in patients with
      very early vs early postnatal discharge.

      Methods A prospective, randomized clinical study was performed with healthy term infants born
      in a hospital in Mexico from July 2016 to June 2018. Sample was randomized into two groups, a
      very early discharge group (<24 hours) and an early discharge group (24-48 hours). Hospital
      readmission rate was analyzed in both groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: They were selected based on a random computer program in a 1: 1 model, assigning each subject randomly to one of the two study groups
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Outcome assessors consisted of hospital staff not involved in the investigation.
measure: Hospital readmission rate
time frame: 28 days
description: Proportion of participant newborns who were readmitted into the hospital during follow up
measure: Rate of attention in emergency services
time frame: 28 days
description: Proportion of participant newborns who attended the emergency services during follow up
measure: Readmission rate associated factors
time frame: 28 days
description: Statistical associations between the primary outcome and other variables of interest
arm group label: Early discharge
arm group type: Active Comparator
description: Discharge between 24 and 48 hours
arm group label: Very early discharge
arm group type: Experimental
description: Discharge in less than 24 hours
intervention type: Other
intervention name: Time to discharge less than 24 hours
description: Allow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
arm group label: Very early discharge
intervention type: Other
intervention name: Discharge time between 24 and 48 hours
description: Allow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
arm group label: Early discharge
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 2 Days
healthy volunteers: No
last name: Erika Ochoa-Correa, M.D.
role: Principal Investigator
affiliation: Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics
url: http://www.cndh.org.mx/sites/all/doc/Programas/VIH/Leyes%20y%20normas%20y%20reglamentos/Norma%20Oficial%20Mexicana/NOM-007-SSA2-2016%20Embarazo,%20parto%20y%20puerperio.pdf
description: Norma Oficial Mexicana NOM-007-SSA2-2016 para la atención de la mujer durante el embarazo, parto y puerperio, y de la persona recién nacida.
citation: Jones E, Taylor B, MacArthur C, Pritchett R, Cummins C. The effect of early postnatal discharge from hospital for women and infants: a systematic review protocol. Syst Rev. 2016 Feb 8;5:24. doi: 10.1186/s13643-016-0193-9.
PMID: 26857705
citation: Brown S, Small R, Faber B, Krastev A, Davis P. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2002;(3):CD002958. doi: 10.1002/14651858.CD002958.
PMID: 12137666
citation: Benitz WE; Committee on Fetus and Newborn, American Academy of Pediatrics. Hospital stay for healthy term newborn infants. Pediatrics. 2015 May;135(5):948-53. doi: 10.1542/peds.2015-0699.
PMID: 25917993
citation: Chalmers B, Mangiaterra V, Porter R. WHO principles of perinatal care: the essential antenatal, perinatal, and postpartum care course. Birth. 2001 Sep;28(3):202-7. doi: 10.1046/j.1523-536x.2001.00202.x.
PMID: 11552969
citation: Capurro H, Konichezky S, Fonseca D, Caldeyro-Barcia R. A simplified method for diagnosis of gestational age in the newborn infant. J Pediatr. 1978 Jul;93(1):120-2. doi: 10.1016/s0022-3476(78)80621-0. No abstract available.
PMID: 650322
citation: SILVERMAN WA, ANDERSEN DH. A controlled clinical trial of effects of water mist on obstructive respiratory signs, death rate and necropsy findings among premature infants. Pediatrics. 1956 Jan;17(1):1-10. No abstract available.
PMID: 13353856
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Nuevo Leon
investigator full name: Erika Ochoa-Correa
investigator title: Professor
sharing ipd: No