Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

NCT05208437 | Completed

• 1 other identifier: [2021]394
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

Conditions

Premature Infants

Keywords

premature infants; oral feeding

Outcome Measures

Primary Outcomes (1)

• Transition time from the initiation oral feeding to full oral feeding

  Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle. time of complete oral feeding

  During the procedure

Study Arms (2)

Complete oral feeding intervention group

EXPERIMENTAL

Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale. Feeding of premature infants using different interventions based on the results of the Feeding Preparation Scale.

Behavioral: Complete oral feeding intervention

Routine nursing care group

ACTIVE COMPARATOR

Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding. Routine nursing care is identical to the control group.

Behavioral: Routine nursing care group

Interventions

Complete oral feeding intervention BEHAVIORAL

Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale by trained nurses. Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding. If the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant.

Complete oral feeding intervention group

Routine nursing care group BEHAVIORAL

Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding.

Routine nursing care group

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \<32w;
• Admit within 72 hours of birth;
• The guardian signs the informed consent;
• OI (oxygenation index \>300)

You may not qualify if:

• Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
• Newborns who die during the study;
• Newborns who drop out of the study;
• Newborns who have NEC during hospitalization

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Xiaojing Hu, PhD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 26, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-02

Locations

CN (1)