Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns

NCT04422041 | Completed

• 1 other identifier: PE15-039
• Study Type: interventional
• Target: 354
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients.

Conditions

Hospital Readmission; Newborn Morbidity; Newborn Complication; Newborn

Keywords

Newborn Infant; Hospital readmission; Early discharge; Very early discharge

Outcome Measures

Primary Outcomes (1)

• Hospital readmission rate

  Proportion of participant newborns who were readmitted into the hospital during follow up

  28 days

Secondary Outcomes (2)

• Rate of attention in emergency services

  28 days

• Readmission rate associated factors

  28 days

Study Arms (2)

Early discharge

ACTIVE COMPARATOR

Discharge between 24 and 48 hours

Other: Discharge time between 24 and 48 hours

Very early discharge

EXPERIMENTAL

Discharge in less than 24 hours

Other: Time to discharge less than 24 hours

Interventions

Time to discharge less than 24 hours OTHER

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.

Very early discharge

Discharge time between 24 and 48 hours OTHER

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.

Early discharge

Eligibility Criteria

• Age: 1 Minute - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy newborns that were born from vaginal delivery in primiparous or multiparous women where both the mother and the newborn were deemed as eligible for early discharge according to the American Association of Pediatrics criteria and by a clinical obstetric mother evaluation.

You may not qualify if:

• Placenta praevia, abnormal bleeding during vaginal delivery (considered as greater than 500mL), inhability to deambulate, medical complications from previous a previous pregnancy, 3rd or 4th degree perineal laceration as well as medical conditions that required any monitorization for more than 24 hours after delivery.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• 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.

Study Officials

• Erika Ochoa-Correa, M.D.

  Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors consisted of hospital staff not involved in the investigation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2016
• Primary Completion: June 29, 2018
• Study Completion: July 29, 2018
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share