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

Newborn Clinical Trial

Official title:

Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422041
• Other study ID #: PE15-039
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: July 29, 2018

Study information

• Verified date: June 2020
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: July 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hospital Readmission
• Newborn
• Newborn Complication
• Newborn Morbidity

Intervention

Other:
• Time to discharge less than 24 hours
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.
• Discharge time between 24 and 48 hours
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmission rate	Proportion of participant newborns who were readmitted into the hospital during follow up	28 days
Secondary	Rate of attention in emergency services	Proportion of participant newborns who attended the emergency services during follow up	28 days
Secondary	Readmission rate associated factors	Statistical associations between the primary outcome and other variables of interest	28 days

External 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.