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

Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants Whose Corrected Gestational Age Are Less Than 32 Weeks

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

Study Overview

• Status: Completed
• Conditions: Premature Infants
• Intervention / Treatment: Behavioral: Complete oral feeding intervention; Behavioral: Routine nursing care group

Detailed Description

In order to improve the feeding of premature infants <32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.

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. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants <32 weeks of gestation.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 days (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complete oral feeding intervention group; 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; 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.
Active Comparator: Routine nursing care group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Xiaojing Hu, PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: oral feeding; premature infants
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: [2021]394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No